drugset / Trial / NCT01395758
Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.
Timeline
- Start
- 2011-07
- Primary completion
- 2016-08
- Completion
- 2016-08
Outcome
Missed primary endpoint
registry analysis (superiority test); Tivantinib Plus Erlotinib Arm vs Chemotherapy Arm; p = 0.5017; Log Rank NCT01395758 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | — | — |
| Subject | Erlotinib | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Pemetrexed | Small molecule | — | — |
| Subject | Tivantinib | Small molecule | — | — |