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A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Recruiting
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Phase 1/2, dose escalation and expansion study designed to evaluate the safety and
tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the
antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid
tumors.
Phase 1 will evaluate the overall safety and tolerability of NVL-655 and will determine the
RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors.
Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent
Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration
of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival
(OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC
and other solid tumors.
Stanford Investigators
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Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors
Recruiting
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This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study,
evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect of
biomarkers of XL092 administered alone, and in combination with nivolumab (doublet),
nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in subjects with
advanced solid tumors.
In the Expansion Stage, the safety and efficacy of XL092 as monotherapy and in combination
therapy will be further evaluated in tumor-specific Expansion Cohorts.
Stanford Investigators
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A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
Not Recruiting
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Phase 1/2, dose escalation and expansion study designed to evaluate the safety and
tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the
antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced
ROS1-positive solid tumors.
Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of
NVL-520 in patients with advanced ROS1-positive solid tumors.
Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent
Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration
of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival
(OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive
NSCLC and other solid tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)
Not Recruiting
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The goal of this clinical study is to learn more about the study drug, sacituzumab
govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a
platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic
(cancer that has spread) non-small-cell lung cancer (NSCLC).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Not Recruiting
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The purpose of this study is to assess the anti-tumor activity and safety of amivantamab
which will be administered as a co-formulation with recombinant human hyaluronidase PH20
(rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except
Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Recruiting
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This phase III trial compares the effect of bevacizumab and osimertinib combination vs.
osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of
the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein
is involved in cell signaling pathways that control cell division and survival. Sometimes,
mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on
some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may
stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type
of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of
tumor cells to grow and spread. Giving osimertinib with bevacizumab may control cancer for
longer and help patients live longer as compared to osimertinib alone.
Stanford Investigators
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Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer
Not Recruiting
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This phase II trial compares cabozantinib alone and the combination of cabozantinib and
nivolumab to standard chemotherapy in the treatment of patients with non-squamous non-small
cell lung cancer (NSCLC). Cabozantinib may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as
nivolumab, may help the body's immune system attack the cancer, and may interfere with the
ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may
interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as
docetaxel, gemcitabine hydrochloride, paclitaxel, and nab-paclitaxel, work in different ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Giving cabozantinib alone or in combination
with nivolumab may be more effective than standard chemotherapy in treating patients with
non-small cell lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Site Public Contact, 650-498-7061.
Stanford Investigators
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A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
Recruiting
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The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D)
of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2
combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to
characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the
RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented
advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion
cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab
combinations at the RP2CD in participants with advanced NSCLC with documented advanced or
metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the
biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of
Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in
participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated
NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with
Amivantamab and standard of care chemotherapy and to determine the tolerability of the
Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP
combination cohort) and to characterize the safety and tolerability of Lazertinib at the
RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or
metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential
biomarker strategies to identify participants at increased, or decreased, probability of
tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR
Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion
Cohort D).
Stanford Investigators
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TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
Recruiting
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The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment
with that of platinum-based chemotherapy in participants with locally advanced or metastatic
non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR)
exon 20 insertion mutations.
Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or
Platinum-based chemotherapy group.
Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin
via vein until the participants experience worsening disease (PD) as assessed by blinded
independent review committee (IRC), intolerable harmful effects or another discontinuation
criteria.
Stanford Investigators
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Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy
Not Recruiting
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This is a Phase III, multicenter, randomized, open-label study designed to evaluate the
efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib
compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing
EGFR mutation or ALK translocation, who have progressed following treatment with
platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or
sequentially.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Recruiting
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In this study circulating tumor DNA (ctDNA) blood testing is used to detect the residual
blood cancer. If residual cancer using this blood test is detected there may be at higher
risk of having the cancer return. The study is going to test whether or not the number of
circulating cancer cells detected in the blood can be reduced by administration durvalumab
after the standard treatment if you are tested positive for the residual cancer.
Lead Sponsor
Stanford Investigators
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Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
Not Recruiting
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This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous
non-small cell lung cancer that is stage IV or has come back (recurrent) and has a specific
mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may cause the cancer to
grow. AMG 510, a targeted treatment against the KRAS G12C mutation, may help stop the growth
of tumor cells.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab
Not Recruiting
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This trial will evaluate safety and tolerability of letetresgene autoleucel (GSK3377794) with
or without pembrolizumab in participants with non-small cell lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
Not Recruiting
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RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an
effective treatment for extensive stage small cell lung cancer.
PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain
works when given with or without radiation therapy to other areas of the body in treating
patients with extensive stage small cell lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Laura Gable, 6507360798.
Stanford Investigators
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MAGE A10ᶜ⁷⁹⁶T for Advanced NSCLC
Recruiting
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This first time in human study is intended for men and women at least 18 years of age who
have advanced lung cancer which has grown or returned after being treated. In particular, it
is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and
a tumor test positive for MAGE A10 protein expression (protein or gene). This trial is a dose
escalation trial that will evaluate 3 doses of transduced cells administered after a
lymphodepleting chemotherapy regimen using a 3+3 dose escalation design .The study will take
the subject's T cells, which are a natural type of immune cell in the blood, and send them to
a laboratory to be modified. The changed T cells used in this study will be the subject's own
T cells that have been genetically changed with the aim of attacking and destroying cancer
cells.
When the MAGE A10ᶜ⁷⁹⁶T cells are available, subjects will receive lymphodepleting
chemotherapy with cyclophosphamide and fludarabine, followed by the T cell infusion. The
purpose of this study is to test the safety of genetically changed T cells and find out what
effects, if any, they have in subjects with lung cancer. The study will evaluate three
different cell dose levels in order to find out the target cell dose. Once the target cell
dose is determined, additional subjects will be enrolled to further test the safety and
effects at this cell dose.
Subjects will be seen frequently by the Study Physician right after receiving their T cells
back and up to first 6 months. After that, subjects will be seen every three months. Subjects
will be seen every 6 months by their Study Physician for the first 5 years after the T cell
infusion. If the T cells are found in the blood at five years, then the subjects will
continue to be seen once a year until the T cells are no longer found in the blood for a
maximum of 15 years. If the T cells are no longer found in the blood at 5 years, then the
subject will be contacted by the Study Physician for the next 10 years. Subjects who have a
confirmed response or clinical benefit ≥4 weeks after the first T-cell infusion and whose
tumor continues to express the appropriate antigen target may be eligible for a second
infusion. All subjects, completing or withdrawing from the Interventional Phase of the study,
will enter a 15-year long-term follow-up phase for observation of delayed adverse events. All
subjects will continue to be followed for overall survival during the long-term follow-up
phase.
Stanford Investigators
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Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer
Not Recruiting
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AC0010MA is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective
Tyrosine Kinase Inhibitor. Aim at local advanced or metastatic non-small cell lung cancer
patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by
irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the
activities of EGFR tyrosine kinase phosphorylation, block the signal transduction pathway of
EGFR and inhibit the function of ras/raf/MAPK downstream, thus block the tumor cell growth by
EGFR induction, and promotes apoptosis. AC0010MA Maleate Capsules has three characters: 1.
Irreversible binding to EGFR; 2. Effectively suppresses the tumor cell with EGFR mutant while
has no suppression to EGFR wild-type cell; 3. Efficient suppress the tumor cell with EGFR
T790M drug-resistant mutation.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]
Not Recruiting
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This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab
(MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC.
Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab
(MPDL3280A) on Day 1 of 21-day cycles until disease progression.
Eligible participants will be categorized in to three groups as follows:
1. Participants with no prior chemotherapy for advanced disease;
2. Participants who progress during or following a prior-platinum based chemotherapy
regimen for advanced disease (2L+participants);
3. Participants who are 2L+ and previously treated for brain metastases.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lisa Zhou, 650-736-4112.
Stanford Investigators
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PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients
Not Recruiting
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The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or
recommended dose for expansion (RDE) of PDR001 when administered in combination with
platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients
with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumor activity in
this patient population.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer
Recruiting
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This screening and multi-sub-study randomized phase II/III trial will establish a method for
genomic screening of similar large cancer populations followed by assigning and accruing
simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer
trait (biomarker) will determine to which sub-study, within this protocol, a participant will
be assigned to compare new targeted cancer therapy, designed to block the growth and spread
of cancer, or combinations to standard of care therapy with the ultimate goal of being able
to approve new targeted therapies in this setting. In addition, the protocol includes
non-match sub-studies which will include all screened patients not eligible for any of the
biomarker-driven sub-studies.
Stanford Investigators
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Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor
Not Recruiting
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This phase I trial studies the side effects and best dose of necitumumab when given together
with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is
stage IV or has come back after a period of improvement (recurrent) and who have progressed
on a previous EGFR tyrosine kinase inhibitor. Immunotherapy with monoclonal antibodies, such
as necitumumab, may induce changes in body's immune system and may interfere with the ability
of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may be a
better treatment for EGFR-mutant non-small cell lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Sukhmani K. Padda, 650-498-7061.
Stanford Investigators
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Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
Not Recruiting
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In this research study erlotinib will be given to eligible participants whose lung cancer has
been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung
cancer, and must have 1 or more of the following characteristics: be female, be of Asian or
Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be
examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is
overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific
mutations and the participant must have one of these mutations in his tumor.
Erlotinib blocks this protein and may control tumor growth and increase survival. Previous
research has shown that erlotinib is most effective for people who have these specific
mutations in the EGFR.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lei Shura, 650-723-2312.
Stanford Investigators
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Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Not Recruiting
More
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium
may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not
yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more
effective in treating non-squamous non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium
alone or in combination after induction therapy to see how well they work in treating
patients with advanced non-squamous non-small cell lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lisa Zhou, 6507364112.
Stanford Investigators
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A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
Not Recruiting
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This phase II, open-label, randomized study will evaluate the efficacy and safety of
MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of
the head and neck who have progressed during or following platinum-based chemotherapy.
Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2
weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients
treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation
of progressive disease and upon meeting eligibility criteria. Anticipated time on study
treatment is until disease progression or intolerable toxicity occurs.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ruth Lira, 6507231367.
Stanford Investigators
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Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients
Not Recruiting
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The primary aim of this study is to determine whether we can identify human lung cancer tumor
cells in the peripheral blood of lung cancer patients.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lisa Zhou, 650-736-4112.
Lead Sponsor
Stanford Investigators
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A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies
Not Recruiting
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A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or
thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for
thymic cancers.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo, 650-724-1388.
Stanford Investigators
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An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Not Recruiting
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This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients
with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene.
This trial will also allow patients from a Phase 3 trial who received standard of care
chemotherapy (Study A8081007) to receive PF-02341066.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo, 6507241388.
Stanford Investigators
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Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
Not Recruiting
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The purpose of this study is to determine the maximum tolerated dose (MTD) of vorinostat
given concurrently with stereotactic radiosurgery (SRS) to treat non-small cell lung cancer
(NSCLCA) brain metastases in patient with 1-4 lesions.
Stanford is currently not accepting patients for this trial.
For more information, please contact Maria Coburn, 6507369551.
Lead Sponsor
Stanford Investigators
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Radical-Dose Image Guided Radiation Therapy in Treating Patients With Metastatic Non-small Cell Lung Cancer Undergoing Immunotherapy
Not Recruiting
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This phase II trial studies how well radical-dose image guided radiation therapy works in
treating patients with non-small cell lung cancer that has spread to other places in the body
who are undergoing immunotherapy. Radiation therapy uses high energy x-rays to kill tumor
cells and shrink tumors. Giving radical-dose image guided radiation therapy to patients with
non-small cell lung cancer may help to improve response to immunotherapy anti-cancer
treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact Kim Nguyen, 650-497-8966.
Lead Sponsor
Stanford Investigators
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BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Not Recruiting
More
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine
therapy together with bevacizumab after chemotherapy and radiation therapy may kill more
tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccine
together with bevacizumab after chemotherapy and radiation therapy in treating patients with
newly diagnosed stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by
surgery.
Stanford is currently not accepting patients for this trial.
For more information, please contact Maria Pitsiouni, 650-721-6977.
Stanford Investigators
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Manuka Honey in Preventing Esophagitis-Related Pain in Patients Receiving Chemotherapy and Radiation Therapy For Lung Cancer
Not Recruiting
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RATIONALE: Manuka honey may prevent or reduce esophagitis-related pain caused by chemotherapy
and radiation therapy. It is not yet known whether Manuka honey is more effective than
standard care in preventing pain.
PURPOSE: This randomized phase II clinical trial is studying Manuka honey to see how well it
works in preventing esophagitis-related pain in patients receiving chemotherapy and radiation
therapy for lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Laura Gable, 6507360798.
Stanford Investigators
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Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation
Not Recruiting
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This research study is a Phase II clinical trial, which tests the safety and effectiveness of
an investigational drug to learn whether the drug works in treating a specific cancer.
"Investigational" means that the drug is still being studied. It also means that the FDA has
not yet approved afatinib for use in patients.
In this research study the investigators are looking to see if taking afatinib after surgery
works better when taken over a short period of time, compared to a long period of time.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lisa Zhou, 650-736-4112.
Stanford Investigators
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A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Not Recruiting
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This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in
participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer
(NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3
weeks as long as participants are experiencing clinical benefit as assessed by the
investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration
attributed to disease progression.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lisa Zhou, 650-736-4112.
Stanford Investigators
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Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
Not Recruiting
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This study is primarily designed to assess the safety and tolerability of AZD4547 at
increasing doses in patients with advanced solid malignancies and for whom no standard
medication options are available. It also assesses the blood levels and action of AZD4547 in
the body over a period of time.
Stanford is currently not accepting patients for this trial.
For more information, please contact Prachi Nandoskar, 650-725-0438.
Stanford Investigators
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A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer
Not Recruiting
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This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone
chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV
non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive
4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum
(cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day
cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum
(cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day
cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy
with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or
pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is
until disease progression or unacceptable toxicity occurs.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie SanPedro-Salcedo, 6507241388.
Stanford Investigators
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Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination
Not Recruiting
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This screening study is intended for men and women ≥ 18 to ≤ 75 years of age who have
advanced solid or hematologic malignancy. The study will assess a subject's human leukocyte
antigen (HLA) subtype and tumor antigen expression profile. Based on the results, it will be
determined if a subject is eligible to be considered for Adaptimmune sponsored clinical
trials testing the safety and efficacy of genetically changed T cells targeting specific
tumor antigens. No treatment intervention will occur as part of this screening study.
Upon enrollment, subjects will be required to provide a blood sample for HLA subtype
analysis. If the results of the analysis match the HLA-A subtypes noted in the inclusion
criteria and do not express the HLA subtypes that are exclusionary for the available
interventional clinical trial(s), then the subject will be required to provide either an
archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at
a central laboratory for the expression (protein or gene) of multiple antigens which may
include, but are not limited to MAGE-A4. Based upon the results of these diagnostic analyses,
if eligible, subjects will be referred to an appropriate available interventional clinical
trial(s) at the discretion of the Investigator.
Following screening, tumor samples will be retained by Adaptimmune for the purpose of
developing and validating in vitro diagnostic (IVD) assay(s) for antigen expression profiling
which is required for regulatory approval of a new therapeutic product indication.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Not Recruiting
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This is a Phase III, global, multicenter, open-label, randomized study to compare the
efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A)
treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA
non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured
by disease-free survival (DFS) as assessed by the investigator and overall survival (OS).
Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will
be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors
Not Recruiting
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Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer
(SCLC) and other high-grade neuroendocrine tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact CCTO, 650-498-7061.
Stanford Investigators
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A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer
Recruiting
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This study is about a medicine called TAK-788, also known as mobocertinib, given to adults
with non-small cell lung cancer. The main aims of this study are to check if there are any
side effects from TAK-788, to learn how TAK-788 is processed by the body, and to determine
the best dose of TAK-788 to treat this condition. Participants will take TAK-788 capsules
with chemotherapy. Participants will continue to take TAK-788 unless they or their doctor
decide they should stop this treatment. Participants will take TAK-788 capsules with or
without chemotherapy under antidiarrhea prevention to determine the safety of TAK-788
treatment. Non-Asian, non-White participants will take TAK-788 to determine the safety and
tolerability of TAK-788 treatment.
Stanford Investigators
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Molecular Analysis of Thoracic Malignancies
Recruiting
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A research study to learn about the biologic features of cancer development, growth, and
spread. We are studying components of blood, tumor tissue, normal tissue, and other fluids,
such as urine, cerebrospinal fluid, abdominal or chest fluid in patients with cancer. Our
analyses of blood, tissue, and/or fluids may lead to improved diagnosis and treatment of
cancer by the identification of markers that predict clinical outcome, markers that predict
response to specific therapies, and the identification of targets for new therapies.
Lead Sponsor
Stanford Investigators
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Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)
Recruiting
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This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA
non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in
a patient's tumor cells may help doctors select the best treatment for patients that have
certain genetic changes.
Stanford Investigators
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Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma
Not Recruiting
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Patients with pleural mesothelioma that can not be surgically removed will receive
durvalumab, in combination with standard chemotherapy of pemetrexed and cisplatin as
first-line treatment.
Durvalumab is a type of drug called a monoclonal antibody (a type of protein). Laboratory
tests show that it works by allowing the immune system to detect your cancer and reactivates
the immune response. This may help to slow down the growth of cancer or may cause cancer
cells to die.
The purpose of this study is to see whether adding durvalumab to standard chemotherapy will
improve overall survival (OS).
Stanford is currently not accepting patients for this trial.
For more information, please contact Martina Steffen, 650-721-4077.
Stanford Investigators
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Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)
Not Recruiting
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This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to
observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has
been completely removed by surgery (resected). Erlotinib hydrochloride may stop the growth of
tumor cells by blocking some of the enzymes needed for cell growth.
Stanford is currently not accepting patients for this trial.
For more information, please contact Heather A. Wakelee, 650-724-3697.
Stanford Investigators
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Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer
Not Recruiting
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This randomized phase II trial studies how well positron emission tomography (PET)/computed
tomography (CT)-guided radiation therapy works compared to standard radiation therapy in
treating patients with stage III non-small cell lung cancer. Radiation therapy uses
high-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans,
to guide the radiation therapy, may help doctors deliver higher doses directly to the tumor
and cause less damage to healthy tissue.
Stanford is currently not accepting patients for this trial.
For more information, please contact Laura Gable, 650-736-0798.
Stanford Investigators
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Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer
Not Recruiting
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This screening and multi-sub-study randomized phase II/III trial will establish a method for
genomic screening of similar large cancer populations followed by assigning and accruing
simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer
trait (biomarker) will determine to which sub-study, within this protocol, a participant will
be assigned to compare new targeted cancer therapy, designed to block the growth and spread
of cancer, or combinations to standard of care therapy with the ultimate goal of being able
to approve new targeted therapies in this setting. In addition, the protocol includes a
?non-match? sub-study which will include all screened patients not eligible for any of the
biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of
care also with the goal of approval.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
Recruiting
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This randomized phase III trial studies how well crizotinib works in treating patients with
stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation
in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make
it very active and important for tumor cell growth and progression. Crizotinib may stop the
growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an
effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.
Stanford Investigators
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A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors
Not Recruiting
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This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in
combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid
tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy
Not Recruiting
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The purpose of this study is to compare the anti-tumor efficacy of oral single-agent
rociletinib, as measured by investigator assessment of the PFS, with that of single-agent
cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure
of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing doublet
chemotherapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo, 650-724-1388.
Stanford Investigators
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SABR-ATAC: A Trial of TGF-beta Inhibition and Stereotactic Ablative Radiotherapy for Early Stage Non-small Cell Lung Cancer
Not Recruiting
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The SABR-ATAC trial (Stereotactic Ablative Radiotherapy and anti-TGFB Antibody Combination)
is a phase I/II trial that studies the side effects and efficacy of fresolimumab, an
anti-transforming growth factor beta (TGFB) antibody, when given with stereotactic ablative
radiotherapy in patients with stage IA-IB non-small cell lung cancer. Fresolimumab may
inhibit radiation side effects and block tumor growth through multiple mechanisms.
Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiotherapy
(SBRT), is a specialized form of radiation therapy that precisely delivers high dose
radiation directly to tumors, thus killing tumor cells and minimizing damage to normal
tissue. Giving fresolimumab with SABR may work better in treating patients with early stage
non-small cell lung cancer than treating with SABR alone.
Stanford is currently not accepting patients for this trial.
For more information, please contact Laura Gable, 650-736-0798.
Stanford Investigators
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A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
Not Recruiting
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In this four-part study, NKTR-214 was administered in combination with nivolumab and
with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 +
nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the
doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet
therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214
+ nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet
combination at dosing schedules from Part 3.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
Not Recruiting
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This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants
with non-small cell lung cancer (NSCLC) who had experienced disease progression after
platinum-containing systemic therapy. Participants were assigned randomly to receive either
pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel
75 mg/m^2 Q3W. The total number of participants randomized depended upon demonstration of
sufficient objective responses at an interim analysis.
Eligible participants who were allocated to the first course of pembrolizumab (2 mg/kg Q3W or
10 mg/kg Q3W) and experienced disease progression, to be permitted to receive a second course
of pembrolizumab as long as Inclusion/Exclusion criteria were met.
Protocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were
allocated to docetaxel and experienced disease progression, to be permitted to switch over to
receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met.
With Protocol Amendment 15 (effective date: 03 Jan 2018), all second course and switch over
participants will receive pembrolizumab 200 mg Q3W. Response or progression during the second
and switch over pembrolizumab courses will not count towards efficacy outcome measures, and
adverse events during the second and switch over pembrolizumab courses will not count towards
safety outcome measures.
Also with Amendment 15, once a participant has achieved the study objective or the study has
ended, the participant will be discontinued from this study and enrolled in an extension
study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment.
Switch over participants who have not transitioned to pembrolizumab will be considered for
the extension study on a case-by-case basis.
The primary study hypotheses are that pembolizumab prolongs Overall Survival (OS) and
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1
(RECIST 1.1) by independent radiologists' review in previously-treated participants with
NSCLC in the strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to
docetaxel and in participants whose tumors express PD-L1 compared to docetaxel.
Stanford is currently not accepting patients for this trial.
For more information, please contact Smriti Rai, 650-723-0270.
Stanford Investigators
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Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
Not Recruiting
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RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or
observation works in treating patients with malignant pleural mesothelioma without
progressive disease after first-line chemotherapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ekaterina Dib, 650-723-0503.
Stanford Investigators
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Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
Not Recruiting
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This is the first human study to use X-396 (ensartinib), a drug being developed for treatment
of advanced cancers. The initial purpose of the study is to determine the largest amount of
X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended
Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor
activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide
early information on how the body handles the drug (pharmacokinetics) and on the efficacy of
X-396.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo, 650-724-1388.
Stanford Investigators
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An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Not Recruiting
More
The purpose of this study is to show that Nivolumab will improve progression free survival in
subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared
to chemotherapy
Stanford is currently not accepting patients for this trial.
For more information, please contact Smriti Rai, 650-723-0270.
Stanford Investigators
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A Phase 1/2 Study to Evaluate MEDI4736
Not Recruiting
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This is a multicenter, open-label, first-time-in-human study with a standard 3+3
dose-escalation phase in participants with advanced solid tumors followed by an expansion
phase in participants with advanced solid tumors. An exploration cohort has been added to
determine the safety using every 4 weeks (Q4W) dosing.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo, 650-724-1388.
Stanford Investigators
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Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer
Not Recruiting
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This phase II trial studies how well pembrolizumab works in treating patients with
non-squamous non-small cell lung cancer which has spread to other places in the body.
Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells
to grow and spread.
Stanford is currently not accepting patients for this trial.
For more information, please contact Richard Quick, 650-723-2983.
Stanford Investigators
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Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Not Recruiting
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This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with
chemoradiation therapy works in treating patients with stage III non-small cell lung cancer.
Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy
that delivers a high dose of radiation directly to the tumor may kill more tumor cells and
cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, etoposide,
paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either
by killing the cells, by stopping them from dividing, or by stopping them from spreading. It
is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib
with chemoradiation therapy in treating patients with non-small cell lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Katie Brown, 650-723-1423.
Stanford Investigators
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Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)
Not Recruiting
More
This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of
momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of
momelotinib (MMB) combined with erlotinib in adults with epidermal growth factor receptor
(EGFR)-mutated, EGFR tyrosine kinase inhibitor (TKI) naive metastatic non-small cell lung
cancer (NSCLC). Participants will be sequentially enrolled to receive progressively
increasing doses of momelotinib (MMB) in combination with erlotinib. Escalation of
momelotinib (MMB) doses will proceed to the MTD, defined as the highest tested dose
associated with dose-limiting toxicities (DLT) during the first 28 days of combined erlotinib
and momelotinib (MMB) treatment. There will be four dose levels and each treatment cycle will
consist of 28 days.
Stanford is currently not accepting patients for this trial.
For more information, please contact Smriti Rai, 650-723-0270.
Stanford Investigators
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Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
Not Recruiting
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Many tumor cells, in contrast to normal cells, have been shown to require the amino acid
glutamine to produce energy for growth and survival. To exploit the dependence of tumors on
glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine
utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors.
This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid
tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling
patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839
capsules orally twice or three times daily.
In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative
Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)
Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase
(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H)
tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation
tumors.
As an extension of Parts 1 & 2, patients will be treated with CB-839 in combination with
standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo.
Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and
CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with
everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M
EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring
KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with
histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated
with cabozantinib in combination with CB-839.
All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),
pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may
predict responsiveness in later studies), and tumor response.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei-Jen Chang, 650-725-0866.
Stanford Investigators
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Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
Not Recruiting
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This randomized phase II trial studies how well giving erlotinib hydrochloride and
cabozantinib-s-malate alone or in combination works as second or third line therapy in
treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and
cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together
with cabozantinib-s-malate is more effective than erlotinib hydrochloride or
cabozantinib-s-malate alone in treating non-small cell lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Maria Pitsiouni, 650-721-6977.
Stanford Investigators
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Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC
Not Recruiting
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Novartis-sponsored, open-label, multi-center, interventional ETP to provide LDK378 to
patients with ALK (+)NSCLC, who have been pre-treated with an ALK inhibitor; except in
countries where ALK inhibitors are not approved or available. The protocol will further
evaluate the safety of LDK378 in patients with ALK(+) NSCLC.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo, 650-724-1388.
Stanford Investigators
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Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations
Not Recruiting
More
The purpose of this research study is to learn if adding hydroxychloroquine (HCQ) to
erlotinib helps treat non-small cell lung cancer (NSCLC). Another goal of this research study
is to learn more about NSCLC and how it may respond to study treatment. Erlotinib (Tarceva)
is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block a protein called the
epidermal growth factor receptor (EGFR). EGFR may control tumor growth and tumor cell
survival. However, although TKI drugs can work for some lung cancer patients for a period of
time, eventually the tumor finds a way to resist or counteract the TKI treatment and it
begins to grow again. Hydroxychloroquine (HCQ) is a drug approved by the FDA for treating
malaria, rheumatoid arthritis, and several other diseases. Laboratory research suggests that
when HCQ is given with a TKI, it may help delay or prevent TKI resistance from developing.
Stanford is currently not accepting patients for this trial.
For more information, please contact Zeina Babetty, 6507232983.
Stanford Investigators
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Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer
Not Recruiting
More
This phase 2 trial evaluates how well pegylated irinotecan (NKTR-102) works in treating
patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or breast
cancer (mBC) that has spread to the brain and does not respond to treatment. Pegylated
irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth.
Stanford is currently not accepting patients for this trial.
For more information, please contact Sophie Bertrand, 650-723-4467.
Stanford Investigators
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A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
Not Recruiting
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This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in
patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC).
Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on
Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and
platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not
progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as
maintenance therapy until disease progression or unacceptable toxicity occurs.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo, 6507241388.
Stanford Investigators
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Phase 1 Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer (NSCLC)
Not Recruiting
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This phase I trial studies the side effects and best dose of giving erlotinib and dovitinib
together to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks the
epidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancer
and dovitinib blocks the fibroblast growth factor receptor (FGFR) and other targets which may
be important to treat lung cancer. The combination of both drugs may work better than either
drug alone, but may also have increased side effects. This trial will look at the side
effects of combining the drugs and look for how effective the combination may be.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lisa Zhou, 6507364112.
Stanford Investigators
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Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Not Recruiting
More
The purpose of this study is to evaluate progression-free survival among subjects with KRAS
mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib
(ARQ 197) compared to single agent chemotherapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Lei Shura, 650-723-2312.
Stanford Investigators
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Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Not Recruiting
More
Docetaxel and cetuximab are FDA-approved for the treatment of squamous cell carcinoma of the
head and neck (SCCHN). Cisplatin and carboplatin, while not FDA-approved for SCCHN, have been
used as standard of care in SCCHN patients in combination with other drugs. This study
evaluates if weekly cisplatin and docetaxel, in combination with cetuximab, is effective in
palliative treatment of patients with SCCHN. These drugs will be given intravenously weekly,
repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse
events.
Stanford is currently not accepting patients for this trial.
For more information, please contact Risa Jiron, 650-736-1598.
Lead Sponsor
Stanford Investigators
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A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers
Not Recruiting
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This is a study of CDX-1127, a therapy that targets the immune system and may act to promote
anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias
and lymphomas), as well as patients with select types of solid tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Jennifer Vargas, 650-723-0371.
Stanford Investigators
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Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
Not Recruiting
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A safety & efficacy clinical study of the investigational medicinal product BYM338 for the
treatment of unintentional weight loss in patients with cancer of the lung or the pancreas
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo, 6507241388.
Stanford Investigators
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Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer
Not Recruiting
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This phase I trial studies how well talactoferrin works in treating patients with relapsed or
refractory non-small cell lung cancer (NSCLC) or squamous cell head and neck cancer.
Biological therapies, such as talactoferrin, may stimulate the immune system in different
ways and stop tumor cells from growing
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo, 6507241388.
Lead Sponsor
Stanford Investigators
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Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer
Not Recruiting
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This randomized phase I/II trial studies the side effects and best dose of veliparib when
given together with or without cisplatin and etoposide and to see how well they work in
treating patients with extensive stage small cell lung cancer or large cell neuroendocrine
non-small cell lung cancer that has spread to other parts of the body. Drugs used in
chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of
tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them
from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Giving cisplatin and etoposide with or without veliparib may work
better in treating patients with extensive stage small cell lung cancer or metastatic large
cell neuroendocrine non-small cell lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Maria Pitsiouni, 650-721-6977.
Stanford Investigators
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A Study of HGS1036 in Combination With Chemotherapy in Subjects With Advanced Solid Malignancies
Not Recruiting
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The primary purpose of this study is to determine the maximally tolerated dose (MTD) of
HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus
carboplatin, cisplatin plus etoposide, or docetaxel.
Stanford is currently not accepting patients for this trial.
For more information, please contact Jennifer Vargas, 650-723-0371 .
Stanford Investigators
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A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges
Not Recruiting
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This was a phase II, multi-center, open-label, five-arm study in which the efficacy and
safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the
brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved
Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm
(including positivity criteria). If documentation of ALK rearrangement as described above was
not locally available, a test to confirm ALK rearrangement was performed by a Novartis
designated central laboratory. Patients waited for the central laboratory result of the ALK
rearrangement status before initiating treatment with ceritinib.
Stanford is currently not accepting patients for this trial.
For more information, please contact Richard A Quick, 650-724-1388.
Stanford Investigators
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Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery
Not Recruiting
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This randomized phase III trial studies chemotherapy and bevacizumab to see how well they
work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage
IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work
in different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Giving more than one drug
(combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as
bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab
also may stop the growth of non-small cell lung cancer by blocking the growth of new blood
vessels necessary for tumor growth. It is not yet known whether chemotherapy is more
effective with or without bevacizumab in treating non-small cell lung cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Maria Pitsiouni, 650-721-6977.
Stanford Investigators
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Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
Not Recruiting
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The purpose of this study is to find out whether Nivolumab will significantly improve overall
survival as compared to therapy of investigator's choice in patients with recurrent or
metastatic head and neck carcinoma.
Stanford is currently not accepting patients for this trial.
For more information, please contact Risa Jiron, 650-736-1598.
Stanford Investigators
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LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
Not Recruiting
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A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd
continued until the patient experienced unacceptable toxicity that precluded further
treatment, discontinued treatment at the discretion of the investigator or patient, started a
new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined
progressive disease (PD) as assessed by the investigator if, in the judgment of the
investigator, there was evidence of clinical benefit. In these patients tumor assessment
would continue as per the schedule of assessments until treatment with LDK378 was permanently
discontinued. Patients who discontinued the study medication in the absence of progression
continued to be followed for tumor assessment until the time of PD as assessed by the
investigator
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro-Salcedo , 650-724-1388.
Stanford Investigators
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Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients
Not Recruiting
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Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI)
that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while
sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK)
and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or
recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of
rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melanie San Pedro Salcedo, 650-724-1388.
Stanford Investigators
View full details
