A Randomized Phase II Study of Capmatinib + Osimertinib with or without Ramucirumab in Participants with EGFR Mutant, MET Amplified Stage IV or Recurrent Non-Small Cell lung Cancer

Protocol : SWOG – S1900G

SCHEMA S1900G

Please Note: Below is only a partial list of eligibility, please contact the Genesys Hurley Cancer Institute, Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss the full list of eligibility.  Thank you!

Eligibility:

1. Participants must have been assigned to S1900G by the SWOG Statistics and Data Management Center (SDMC). Assignment to S1900G is determined by the LUNGMAP protocol.
2. Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of the treating physician) on osimertinib, alone or in combination with other agent(s), as their most recent line of therapy. Any number of prior lines of therapy is allowed.
3. Participants must have a MET amplification determined by tissue-based or bloodbased (circulating tumor DNA [ctDNA]) NGS assay. MET amplifications may have been determined based on tissue submitted for testing by FMI through the LUNGMAP screening protocol or using test results completed outside of the study. Tissue or blood must be obtained after disease progression on osimertinib.
4. Participants must have either measurable disease or non-measurable disease.
5. Participants must have a CT with contrast or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study randomization.
6. Participants must not have received an anti-VEGF or VEGFR inhibitor or MET inhibitor.
7. Participants must not have received any anti-cancer drug (investigational or standard of care drug, except osimertinib) within 21 days prior to sub-study randomization. Note: osimertinib may continue up to the day prior to study treatment initiation.
8. Participants must not have received any radiation therapy within 14 days prior to sub-study randomization.
9. Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study.
10. 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.
11. Participants’ most recent Zubrod performance status must be 0-1.
12. 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.