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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: ARQ 197


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARQ 197<br> | Drug: ARQ 197<br>* ARQ 197:360 mg bid (CYP2C19 EM) or 240mg bid (CYP2C19 PM) erlotinib: 150 mg qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | 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. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the progression free survival | 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 | 30 months | 
| To examine the overall survival | 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 | 30 months | 
| To examine the disease control rate | 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 | 30 months | 
| To estimate the safety profile | 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 | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, c-MET, EGFR mutation-positive, gefitinib, erlotinib, EGFR-TKI resistance