drugset / Trial / NCT02468661
A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.
Timeline
- Start
- 2015-09-23
- Primary completion
- 2017-11-15
- Completion
- 2018-12-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capmatinib | Small molecule | 200 mg | Oral |
| Subject | Capmatinib | Small molecule | 400 mg | Oral |
| Subject | Erlotinib | Small molecule | 150 mg | — |