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.
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
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
None
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood and urine sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Lymphoscintigraphy
Procedure/SurgeryUndergo lymphoscintigraphy scan
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Ramucirumab
Biological/VaccineGiven IV
Tepotinib
DrugGiven PO
Response rate
Rates will be compared using a chi-squared test at the 1-sided 10% level and also presented as the difference in response rates with the associated 80% confidence interval for the difference, Further, response rates and associated 80% confidence interval will be estimated for each arm.
Incidence of treatment-related peripheral edema
The frequency of peripheral edema will be compared using a 2-sided 10% level test of proportions. All-grade peripheral edema will be estimated along with 90% confidence intervals. Data from lymphoscintigraphy imaging will be summarized for baseline and among those with peripheral edema.
Incidence and severity of toxicities
Toxicities combining the treatment arms and within each treatment arm will be reported.
Progression-free survival
Will be estimated using the method of Kaplan-Meier. Will be compared between the arms using a 1-sided 10% level log-rank test. Medians and associated 80% confidence intervals will be estimated using the Brookmeyer-Crowley method.
Overall survival
Will be estimated using the method of Kaplan-Meier. Medians and associated 80% confidence intervals will be estimated using the Brookmeyer-Crowley method.
Establishment of a tissue/blood repository
Click on the lead sponsor to view all of their trials.
SWOG Cancer Research Network
Lead sponsor
National Cancer Institute (NCI)
Collaborator
