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NCT00527735 · ClinicalTrials.gov registry record · Phase 2
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 334
- Enrollment target
NCT00527735: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT00527735 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 334 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (151% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00527735, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 334 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.
Primary Outcome
irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Ipilimumab
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 334 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00527735 record still lists
NCT00527735 is an interventional study that assigns participants to a tested intervention. The registered 334 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (151% higher).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT00527735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00527735 about?
NCT00527735 is a clinical study titled "Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)". The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.
What is the current status of trial NCT00527735?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 334 participants. The study started on 2008-02. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00527735?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Ipilimumab (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00527735?
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 NCT00527735's enrollment target sits among peer trials
334 143rd of 2000 higher than 1,857 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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