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NCT01362296 · ClinicalTrials.gov registry record · Phase 2
An Open-label Study of GSK1120212 Compared With Docetaxel in Stage IV KRAS-mutant Non-small Cell Lung Cancer
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
NCT01362296: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01362296 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 134 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362296, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
Study 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.
Primary Outcome
PFS is defined as the time from RAN until the earliest date of documented radiological PD or DT due to any cause. PD was assessed by the INV according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment
Interventions
- DRUG docetaxel
- DRUG GSK1120212
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT01362296 record still lists
NCT01362296 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which docetaxel is the first listed.
NCT01362296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01362296 about?
NCT01362296 is a clinical study titled "An Open-label Study of GSK1120212 Compared With Docetaxel in Stage IV KRAS-mutant Non-small Cell Lung Cancer". 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 ...
What is the current status of trial NCT01362296?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2011-09. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01362296?
The interventions under investigation include: docetaxel (DRUG), GSK1120212 (DRUG).
Who is sponsoring clinical trial NCT01362296?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01362296's enrollment target sits among peer trials
134 537th of 2000 higher than 1,463 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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