ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Non-small-cell Lung Cancer

Treatments: Drug: ARQ 197

Study type: Interventional

Funder types: Industry

Identifiers

NCT01580735

23-4882 (Registry Identifier)

ARQ 197-007

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ARQ 197

Experimental group

Treatment:

Drug: ARQ 197