Trials / Active Not Recruiting
Active Not RecruitingNCT03940703
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
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)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tepotinib | Participants were administered with Tepotinib orally once daily at a dose of 500 mg. |
| DRUG | Osimertinib | Participants received Osimertinib at a dose of 80 mg orally once daily. |
Timeline
- Start date
- 2019-09-19
- Primary completion
- 2023-05-11
- Completion
- 2026-05-01
- First posted
- 2019-05-07
- Last updated
- 2026-02-27
- Results posted
- 2024-06-04
Locations
179 sites across 17 countries: United States, Belgium, China, France, Germany, Hong Kong, Italy, Japan, Malaysia, Netherlands, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03940703. Inclusion in this directory is not an endorsement.