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A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor Receptor (ATTENTION)
The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.
Details
| Lead sponsor | Kyowa Kirin Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Start date | 2011-07 |
Conditions
- Non-small-cell Lung Cancer
Interventions
- ARQ 197 and Erlotinib
- Placebo and Erlotinib
Primary outcomes
- Overall survival
Countries
Japan