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NCT00806819 · ClinicalTrials.gov registry record · Phase 3
Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC
A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 718
- Enrollment target
- 20
- Study locations
NCT00806819 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that has completed, run by Boehringer Ingelheim. The registered enrollment target is 718 participants, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT00806819, a Phase 3 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 718 participants
- Enrollment target
- 20
- Study locations
Study Summary
The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained.
Conditions Studied
Interventions
- DRUG Pemetrexed
- DRUG pemetrexed
- DRUG Nintedanib (BIBF1120)
- DRUG B12
- DRUG dexamethasone (or corticosteroid equivalent)
Study Locations (20)
Florida
- Boehringer Ingelheim Investigational Site - Aventura
- Boehringer Ingelheim Investigational Site - Boynton Beach
- Boehringer Ingelheim Investigational Site - Jacksonville
- Boehringer Ingelheim Investigational Site - Miami
- Boehringer Ingelheim Investigational Site - New Port Richey
- Boehringer Ingelheim Investigational Site - Port Saint Lucie
- Boehringer Ingelheim Investigational Site - Stuart
California
- Boehringer Ingelheim Investigational Site - Downy
- Boehringer Ingelheim Investigational Site - Fountain Valley
- Boehringer Ingelheim Investigational Site - Fullerton
- Boehringer Ingelheim Investigational Site - Long Beach
Illinois
- Boehringer Ingelheim Investigational Site - Galesburg
- Boehringer Ingelheim Investigational Site - Skokie
Indiana
- Boehringer Ingelheim Investigational Site - Indianapolis
- Boehringer Ingelheim Investigational Site - New Albany
Kentucky
- Boehringer Ingelheim Investigational Site - Ashland
- Boehringer Ingelheim Investigational Site - Louisville
Connecticut
- Boehringer Ingelheim Investigational Site - Meriden
Kansas
- Boehringer Ingelheim Investigational Site - Witchita
Massachusetts
- Boehringer Ingelheim Investigational Site - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 718 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00806819
The ClinicalTrials.gov registry entry for NCT00806819 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 718 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 318-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (126% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Pemetrexed is the first listed.
NCT00806819 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT00806819 about?
NCT00806819 is a clinical study titled "Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC". The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained.
What is the current status of trial NCT00806819?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 718 participants. The study started on 2008-12. Estimated completion is 2015-12.
What conditions does trial NCT00806819 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT00806819?
The interventions under investigation include: Pemetrexed (DRUG), pemetrexed (DRUG), Nintedanib (BIBF1120) (DRUG), B12 (DRUG), dexamethasone (or corticosteroid equivalent) (DRUG).
Who is sponsoring clinical trial NCT00806819?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00806819 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.
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