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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01580735

Enrollment

Registered

2012-04-19

Start date

2012-05-31

Completion date

2015-04-30

Last updated

2015-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell Lung Cancer

Keywords

NSCLC, c-MET, EGFR mutation-positive, gefitinib, erlotinib, EGFR-TKI resistance

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.

Interventions

DRUGARQ 197

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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 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 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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026