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

Phase 2

Completed

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: ARQ 197

• Registration Number: NCT01580735
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Study Start: 2012-05
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-16
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARQ 197	ARQ 197	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	Up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
To examine the overall survival	30 months	To examine the overall survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
To estimate the safety profile	30 months	To estimate the safety profile of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
To examine the disease control rate	30 months	To examine the disease control rate of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib
To examine the progression free survival	30 months	To examine the progression free survival of patients receiving ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib