Overview
ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
Status:
Completed
Completed
Trial end date:
2015-04-01
2015-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kyowa Hakko Kirin Company, Limited
Kyowa Kirin Co., Ltd.Treatments:
Erlotinib Hydrochloride
Criteria
Key Inclusion Criteria:- Histologically or cytologically confirmed surgically unresectable locally advanced or
metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
- Measurable disease and documented disease progression following the first and
immediate EGFR-TKI monotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function
Key Exclusion Criteria:
- Prior therapy with a c-Met inhibitor.
- Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
- Major surgical procedure within 4 weeks prior to randomization
- Known symptomatic brain metastases.