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NCT01450761 · ClinicalTrials.gov registry record · Phase 3
Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
A Phase 3 study of Small Cell Lung Carcinoma, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,351
- Enrollment target
- 20
- Study locations
NCT01450761: Completed Phase 3 study of Small Cell Lung Carcinoma, sponsored by Bristol-Myers Squibb.
NCT01450761 is a Phase 3 study of Small Cell Lung Carcinoma that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,351 participants, above the 186-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (626% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01450761, a Phase 3 study of Small Cell Lung Carcinoma, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,351 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.
Primary Outcome
Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Etoposide
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Placebo matching Ipilimumab
Study Locations (20)
Florida
- Florida Cancer Specialists S. - Fort Myers
- Cancer Specialists, LLC - Jacksonville
- Lake City Cancer Care - Lake City
- Florida Cancer Specialists - St. Petersburg
Illinois
- Quincy Medical Group - Quincy
- Presence Medical Group Hematology Oncology - Skokie
- SIU School Of Medicine - Springfield
Kentucky
- Ashland Bellefonte Cancer Center - Ashland
- University Of Kentucky - Lexington
- Montgomery Cancer Center - Mount Sterling
California
- Sutter Medical Center - Auburn
- UCSD Moores Cancer Center - La Jolla
Arkansas
- Genesis Cancer Center - Hot Springs
Colorado
- University Of Colorado Cancer Center - Aurora
Georgia
- Medical Oncology, LLC - Augusta
Indiana
- St. Francis Medical Group Oncology And Hematology Specialist - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,351 participants |
| Start Date | 2011-12-13 |
| Est. Completion | 2017-05-17 |
| Phase | Phase 3 |
What the finished NCT01450761 record still lists
NCT01450761 is an interventional study that assigns participants to a tested intervention. Its 1,351 participants enrollment target places it among the larger protocols in the corpus, above the 186-participant average among 18 other Small Cell Lung Carcinoma trials with a reported enrollment target (626% higher).
The record links to 1 condition, with Small Cell Lung Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01450761 names 20 study sites across 12 states, led by Florida, Illinois, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01450761 about?
NCT01450761 is a clinical study titled "Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone". The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.
What is the current status of trial NCT01450761?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,351 participants. The study started on 2011-12-13. Estimated completion is 2017-05-17.
What conditions does trial NCT01450761 study?
This clinical trial studies the following conditions: Small Cell Lung Carcinoma.
What interventions are being tested in trial NCT01450761?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Etoposide (DRUG), Ipilimumab (BIOLOGICAL), Placebo matching Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01450761?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01450761 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01450761's enrollment target sits among peer trials
1,351 1st of 18 higher than 18 of 18 other Small Cell Lung Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small Cell Lung Carcinoma 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.
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