Study on Tepotinib and Osimertinib for Treating MET Amplified Non-Small Cell Lung Cancer After Osimertinib Relapse

Sponsor: EMD Serono Research & Development Institute, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT03940703

This clinical trial is testing a combination of two drugs, tepotinib and osimertinib, to see if they can help treat advanced non-small cell lung cancer (NSCLC) that has returned after initial treatment with osimertinib.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the combination of tepotinib, a MET inhibitor, and osimertinib, an EGFR inhibitor, works in treating patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has come back after treatment with osimertinib. The study will also look at the safety and how the body processes these drugs.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by lab tests, with a specific EGFR mutation.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.
  • Have shown resistance to first-line osimertinib treatment, with documented disease progression.
  • Have previously benefited from osimertinib treatment, showing either a partial or complete response, or stable disease lasting more than 6 months.
  • Have only received osimertinib as the first treatment for advanced or metastatic NSCLC.
  • Have MET amplification confirmed by specific tests on tumor or blood samples after progression on osimertinib.
  • Provide tumor and blood samples for MET amplification testing after progression on osimertinib.
  • Other criteria as defined by the study protocol may apply.

Exclusion Criteria

  • Have spinal cord compression or brain metastasis unless they are not causing symptoms, are stable, or do not require steroids for at least 2 weeks before starting the study.
  • Have unresolved side effects from previous cancer treatments, except for hair loss.
  • Have inadequate blood, liver, or kidney function.
  • Have heart problems.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis that required steroid treatment.
  • Have high blood pressure that is not controlled to below 150/90 mmHg.
  • Cannot take osimertinib for any reason.
  • Other criteria as defined by the study protocol may apply.

Locations

FACILITYZIPCITYSTATE
Yuma Regional Medical Center85364YumaArizona
Compassionate Care Research Group Inc - Edinger Medical Group, Inc.92708Fountain ValleyCalifornia
Memorial Care90806Long BeachCalifornia
Ventura County Hematology Oncology Specialists93030OxnardCalifornia
Innovative Clinical Research Institute92801WhittierCalifornia
Eastern Connecticut Hematology & Oncology Associates06360NorwichConnecticut
Holy Cross33308Fort LauderdaleFlorida
Memorial Healthcare System33021HollywoodFlorida
Cancer Specialists of North Florida32256JacksonvilleFlorida
Ocala Oncology34474OcalaFlorida

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