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NCT01285609 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
A Phase 3 study of Lung Cancer - Non Small Cell Squamous, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,289
- Enrollment target
- 20
- Study locations
NCT01285609: Completed Phase 3 study of Lung Cancer - Non Small Cell Squamous, sponsored by Bristol-Myers Squibb.
NCT01285609 is a Phase 3 study of Lung Cancer - Non Small Cell Squamous that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,289 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01285609, a Phase 3 study of Lung Cancer - Non Small Cell Squamous, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,289 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
Primary Outcome
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Ipilimumab
- DRUG Paclitaxel
Study Locations (20)
Illinois
- University Of Illinois At Chicago Medical Center - Chicago
- Quincy Medical Group - Quincy
- Presence Medical Group Hematology Oncology - Skokie
- Southern Illinois University School Of Medicine - Springfield
Kentucky
- Kentucky Cancer Clinic - Hazard
- Norton Cancer Institute - Louisville
- Montgomery Cancer Center - Mount Sterling
Florida
- Lynn Cancer Institute Center For Hematology-Oncology - Boca Raton
- Integrated Community Oncology Network - Jacksonville
Indiana
- St. Francis Hospital & Health Centers - Indianapolis
- Floyd Memorial Cancer Center Of Indiana - New Albany
Missouri
- University Of Kansas Cancer Center - Kansas City
- Washington University School Of Medicine - St Louis
North Carolina
- Durham Va Medical Center (111g) - Durham
- Carolina Biooncology Institute - Huntersville
California
- Sharp Memorial Hospital - San Diego
Connecticut
- Va Connecticut Healthcare System - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,289 participants |
| Start Date | 2011-01-16 |
| Est. Completion | 2017-08-22 |
| Phase | Phase 3 |
What the finished NCT01285609 record still lists
NCT01285609 is an interventional study that assigns participants to a tested intervention. Its 1,289 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% higher).
The record links to 1 condition, with Lung Cancer - Non Small Cell Squamous appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT01285609 names 20 study sites across 11 states, led by Illinois, Kentucky, Florida.
Frequently Asked Questions
What is clinical trial NCT01285609 about?
NCT01285609 is a clinical study titled "Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin". The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
What is the current status of trial NCT01285609?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,289 participants. The study started on 2011-01-16. Estimated completion is 2017-08-22.
What conditions does trial NCT01285609 study?
This clinical trial studies the following conditions: Lung Cancer - Non Small Cell Squamous.
What interventions are being tested in trial NCT01285609?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Ipilimumab (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT01285609?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01285609 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lung Cancer - Non Small Cell Squamous
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01285609's enrollment target sits among peer trials
1,289 197th of 2000 higher than 1,804 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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