Clinical Trial: NCT03940703
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
| Information Provided By: | EMD Serono |
| Last Update Posted: | 2026-08-21 |
Study Overview
Brief 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).
Official Title
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)
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Tepotinib
- Drug: Osimertinib
Other Study ID Numbers
- MS200095_0031
- 2019-001538-33
- 2024-512005-87-00
- CTR20192589
- jRCT2080224898
- JapicCTI-194983
- 2019
Start Date (Actual)
2019-09-19
Primary Completion Date (Actual)
2023-05-11
Study Completion Date (Actual)
2026-07-15
Enrollment (Actual)
140
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
| Information Provided By: | EMD Serono |
| Last Update Posted: | 2026-08-21 |
Study Overview
Brief 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).
Official Title
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)
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Tepotinib
- Drug: Osimertinib
Other Study ID Numbers
- MS200095_0031
- 2019-001538-33
- 2024-512005-87-00
- CTR20192589
- jRCT2080224898
- JapicCTI-194983
- 2019
Start Date (Actual)
2019-09-19
Primary Completion Date (Actual)
2023-05-11
Study Completion Date (Actual)
2026-07-15
Enrollment (Actual)
140
Study Type
Interventional
Phase
Phase 2