A Phase II Study of Tepotinib in Patients with Stage IIIB-IV Lung Adenocarcinoma

Full Title

A Phase II Single-arm Trial to Investigate Tepotinib in Stage IIIB/IV Adenocarcinoma of the Lung with MET exon 14 (METex14) Skipping Alterations After Failure of At Least One Prior Active Therapy, Including a Platinum-Doublet-Containing Regimen

Purpose

Tepotinib is an investigational drug that can shrink tumors that have an altered version of the MET protein. In this study, researchers are evaluating the safety and effectiveness of tepotinib is patients with stage IIIB-IV lung adenocarcinomas that contain altered MET and which continued to grow despite at least one regimen of chemotherapy. Tepotinib is a tablet that is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIIB-IV lung adenocarcinoma that has continued to grow despite one but no more than two prior regimens of chemotherapy, at least one of which contained a platinum drug.
  • Patients' tumors must contain a MET exon 14 splice site mutation.
  • At least 3 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study or to inquire about eligibility, please contact Dr. Paul K. Paik at 646-888-4202.

Protocol

16-1065

Phase

II

Investigator

Co-Investigators