Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)

Recruiting now · Phase 2

Conditions studied: Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

In brief

This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.

Key facts

Study ID

NCT06031688

Run by

SWOG Cancer Research Network

People needed

56

Starts

2024-08-08

Expected to finish

2028-05-31

Last updated by the study team

2026-05-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is determined by the LUNGMAP protocol
• Participants must have documentation of stage IV or recurrent NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA [ctDNA]) next generation sequencing (NGS) assay done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Documentation must either be:
• NGS test results from tissue submitted for LUNGMAP screening, or
• Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a MET exon 14 skipping mutation from a previously completed tissue or blood-based NGS test
• Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality, otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable
• Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization
• Participants must not have leptomeningeal disease, spinal cord compression or brain metastases unless:
• Metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization, AND
• Participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study randomization
• Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation
• Participants who have received at least one line of systemic treatment for stage IV or recurrent NSCLC must have progressed (in the opinion of the treating physician) following the most recent line of therapy. Participants who have not yet received systemic treatment for their stage IV or recurrent NSCLC are allowed
• Participants may have received any number of lines of therapy for stage IV or recurrent NSCLC (including zero) and must be able to report prior treatment information
• Participants must have recovered (=< grade 1) from any side effects of prior therapy for NSCLC except alopecia and vitiligo
• Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization
• Participants must not have received treatment with prior MET inhibitor therapies (e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib).
• Participants must not have received treatment with prior angiogenesis inhibitor therapies (including but not limited to bevacizumab and ramucirumab)
• Participants must not have a history of interstitial lung disease that required steroid treatment
• Participants must not have received any radiation therapy within 7 days prior to sub-study randomization with the exceptions of
• Stereotactic radiation to CNS metastases which must have been completed at least 3 days prior to sub-study randomization and
• Palliative radiotherapy to bone metastases which must have been completed at least 1 day prior to sub-study randomization
• Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
• Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
• Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
• Absolute neutrophil count >= 1.5 x 10\^3/uL (within 28 days prior to sub-study randomization)
• Hemoglobin >= 9.0 g/dL (within 28 days prior to sub-study randomization)

Where it is running

• Palo Alto Medical Foundation-Santa Cruz — Santa Cruz, California, United States (enrolling)
• Cedars-Sinai Cancer - Tarzana — Tarzana, California, United States (enrolling)
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Mills Health Center — San Mateo, California, United States (enrolling)
• Sutter Pacific Medical Foundation — Santa Rosa, California, United States (enrolling)
• Palo Alto Medical Foundation-Sunnyvale — Sunnyvale, California, United States (enrolling)
• Thomas Hospital — Fairhope, Alabama, United States (enrolling)
• Sutter Medical Center Sacramento — Sacramento, California, United States (enrolling)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
• Kaiser Permanente-San Francisco — San Francisco, California, United States (enrolling)
• Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis — Daphne, Alabama, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Palo Alto Medical Foundation-Fremont — Fremont, California, United States (enrolling)
• Mobile Infirmary Medical Center — Mobile, Alabama, United States (enrolling)
• Sutter Auburn Faith Hospital — Auburn, California, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland — Saraland, Alabama, United States (enrolling)
• Sutter Roseville Medical Center — Roseville, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Memorial Medical Center — Modesto, California, United States (enrolling)
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States (enrolling)
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States (enrolling)
• Tower Cancer Research Foundation — Beverly Hills, California, United States (enrolling)
• Eisenhower Medical Center — Rancho Mirage, California, United States (enrolling)
• Torrance Memorial Physician Network - Cancer Care — Torrance, California, United States (enrolling)

Full record on ClinicalTrials.gov

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