CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 140 enrolled
Drug / intervention
Tepotinib +1 moredrug
Likely dose
Tepotinib 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03940703
NCT03940703Phase 2Active

A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)

EMD Serono Research & Development Institute, Inc.·interventional·Posted May 7, 2019·Updated Feb 27, 2026

In Brief

A Phase 2 clinical trial evaluating Tepotinib and Osimertinib for Non-small Cell Lung Cancer. Active but no longer recruiting, targeting 140 participants across 179 sites in 17 countries.

Detailed Summary

This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, China, France, Germany, Hong Kong, Italy, Japan, Malaysia, Netherlands, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, United States, Vietnam

Timeline

Phase 2ActiveOverdue
2020202120222023202420252026
First PostedMay 7, 2019
Enrollment StartSep 19, 2019
Primary CompletionMay 11, 2023
Study CompletionMay 1, 2026
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.2 years ago

Interventions

Tepotinibdrug

Participants were administered with Tepotinib orally once daily at a dose of 500 mg.

Osimertinibdrug

Participants received Osimertinib at a dose of 80 mg orally once daily.