Overview

Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)

Status:
Completed
Trial end date:
2021-08-12
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with gefitinib in partcipants with T790M negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization (Tepotinib/Gefitinib arm versus Chemotherapy arm).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Merck KGaA
Merck KGaA, Darmstadt, Germany
Treatments:
Carboplatin
Cisplatin
Gefitinib
Pemetrexed
Tepotinib