Phase 2 study of ARQ 197 plus erlotinib
Phase 2
- Conditions
- on-small-cell lung cancer
- Registration Number
- JPRN-jRCT2080221766
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 40
Inclusion 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
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate<br>RECIST ver. 1.1
- Secondary Outcome Measures
Name Time Method - Progression free survival<br>- Overall survival <br>- Disease control rate<br>- Number of patients with adverse events<br>RECIST ver. 1.1, CTCAE ver. 4.0