CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 134 enrolled
Drug / intervention
GSK1120212 +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.

Search/NCT01362296
NCT01362296Phase 2Completed

A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared With Docetaxel in 2nd Line Subjects With Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC Stage IV)

GlaxoSmithKline·interventional·Posted May 30, 2011·Updated Jul 11, 2014

In Brief

A Phase 2 clinical trial evaluating GSK1120212 and docetaxel for Lung Cancer, Non-Small Cell. Completed, enrolled 134 participants across 60 sites in 8 countries.

Detailed Summary

This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Greece, Hungary, Italy, Netherlands, South Korea, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2012
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.1 years ago

Interventions

GSK1120212drug

Oral once daily

docetaxeldrug

IV once every 3 weeks