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

Kyowa Kirin Co., Ltd.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small-cell Lung Cancer

Interventions

ARQ 197DRUG

ARQ 197:360 mg bid (CYP2C19 EM) or 240mg bid (CYP2C19 PM) erlotinib: 150 mg qd

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Arakawa-ku, Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: Up to 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 30 months

Data from ClinicalTrials.gov

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