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

Sponsor
Kyowa Kirin Co., Ltd.
Study ID
NCT01377376
Phase
PHASE3
Status
Terminated

Conditions

  • Non-small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARQ 197 and Erlotinib — DRUG
    Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib
  • Placebo and Erlotinib — DRUG
    Oral twice daily administration of placebo and oral once daily administration of erlotinib

Study Details

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.

Key Dates

First listed
Jun 21, 2011
Start date
Jul 31, 2011
Status verified
Dec 2016
Primary completion
Nov 30, 2015

Study Design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARQ 197
    ARQ 197 and Erlotinib
  • Placebo Comparator: Placebo
    Placebo and Erlotinib

Primary Outcome Measure

Overall survival

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