At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 96 enrolled
Drug / intervention
ARQ 197 plus erlotinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized Open-label Study of Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Previously Treated KRAS Mutation Positive Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)·interventional·Posted Jul 18, 2011·Updated Apr 3, 2018
In Brief
A Phase 2 clinical trial evaluating ARQ 197 plus erlotinib and Pemetrexed, docetaxel or gemcitabine for Metastatic Non-Small Cell Lung Cancer. Completed, enrolled 96 participants across 13 sites.
Detailed Summary
The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Non-Small Cell Lung Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedJul 2011
Primary CompletionAug 2016
TodayJul 2026
First PostedJul 18, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 15.0 years ago
Interventions
ARQ 197 plus erlotinibdrug
Eligible subjects will be randomly assigned to receive erlotinib plus ARQ 197.
Pemetrexed, docetaxel or gemcitabinedrug
Investigator's choice of a single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered according to the approved label.