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NCT01642004 · ClinicalTrials.gov registry record · Phase 3
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 272
- Enrollment target
NCT01642004: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01642004 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 272 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01642004, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 272 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.
Primary Outcome
OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the
Interventions
- DRUG Docetaxel
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2012-10-16 |
| Est. Completion | 2021-08-16 |
| Phase | Phase 3 |
What the finished NCT01642004 record still lists
NCT01642004 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT01642004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01642004 about?
NCT01642004 is a clinical study titled "Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)". The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.
What is the current status of trial NCT01642004?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 272 participants. The study started on 2012-10-16. Estimated completion is 2021-08-16.
What interventions are being tested in trial NCT01642004?
The interventions under investigation include: Docetaxel (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01642004?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01642004's enrollment target sits among peer trials
272 1214th of 2000 higher than 785 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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