A Phase 2, Multicenter, Open-label, Single-arm Study of ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
Phase 2
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Non-small-cell Lung Cancer
Both
Non-small-cell Lung Cancer
Trial Information
A Phase 2, Multicenter, Open-label, Single-arm Study of ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response Rate
Outcome Description:
To examine the objective response rate of ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib.
Outcome Time Frame:
Up to 6 months
Safety Issue:
No
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
ARQ 197-007
NCT ID:
NCT01580735
Start Date:
May 2012
Completion Date:
November 2014
Related Keywords:
- Non-Small-Cell Lung Cancer
- NSCLC
- c-MET
- EGFR mutation-positive
- gefitinib
- erlotinib
- EGFR-TKI resistance
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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