NCT01377376

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

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor Receptor

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ARQ 197 and Erlotinib	Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib
DRUG	Placebo and Erlotinib	Oral twice daily administration of placebo and oral once daily administration of erlotinib

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-11-01
• First posted: 2011-06-21
• Last updated: 2016-12-07

Locations

1 site across 1 country: Japan