A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib

Phase 3

Terminated

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: Placebo and Erlotinib; Drug: ARQ 197 and Erlotinib

• Registration Number: NCT01377376
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-21
• Study Start: 2011-07
• Primary Completion: 2015-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo and Erlotinib	Placebo and Erlotinib
ARQ 197	ARQ 197 and Erlotinib	ARQ 197 and Erlotinib

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events
Objective response rate		Each assessment will be determined based on RECIST criteria version 1.1 by investigator
Progression free survival