A Phase 2 Study of Targeted Treatment for MET Exon 14 Skipping-Positive Advanced Non-Small Cell Lung Cancer

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Full Title

A Randomized Phase II Study of Tepotinib with or without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study) (S1900K) (CIRB)

Purpose

Researchers are assessing tepotinib with or without ramucirumab in people with non-small cell lung cancer (NSCLC). The people in this study have NSCLC that has metastasized (spread) or recurred (came back) after treatment. Their cancers also have a genetic change called the MET exon 14 skipping mutation.

Tepotinib is used to treat cancer that has a mutated form of a gene called MET. It blocks the action of the abnormal MET protein, which tells cancer cells to multiply. This helps slow or stop the spread of tumor cells. 

Researchers believe that adding ramucirumab to tepotinib might help tepotinib work better to stop cancer cells from multiplying. Ramucirumab may also lessen edema (swelling) in the limbs caused by tepotinib, improving patients’ quality of life.

If you join this study, you will be randomly assigned to get tepotinib alone or with ramucirumab. Tepotinib is taken orally (by mouth) and ramucirumab is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic or recurrent NSCLC that keeps growing even after treatment.
  • Have lung cancer with the MET exon 14 skipping mutation.
  • Have completed prior therapies at least 3 weeks before getting the study treatment.
  • Not have had previous treatment with MET inhibitors (such as crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, or foretinib).
  • Not have had prior therapies that block tumor blood vessel growth (such as bevacizumab or ramucirumab).

Contact

For more information and to see if you can join this study, please call Dr. Paul Paik’s office at 646-608-3759.

Protocol

24-016

Phase

Phase II (phase 2)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06031688