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NCT00656136 · ClinicalTrials.gov registry record · Phase 3
BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 585
- Enrollment target
NCT00656136: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00656136 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 585 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656136, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 585 participants
- Enrollment target
Study Summary
This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed. The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up.
Primary Outcome
Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock. For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010. For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to
Interventions
- DRUG placebo
- DRUG BIBW 2992
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 585 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT00656136 record still lists
NCT00656136 is an interventional study that assigns participants to a tested intervention. The registered 585 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 (24% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00656136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656136 about?
NCT00656136 is a clinical study titled "BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)". This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erloti...
What is the current status of trial NCT00656136?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 585 participants. The study started on 2008-04. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00656136?
The interventions under investigation include: placebo (DRUG), BIBW 2992 (DRUG).
Who is sponsoring clinical trial NCT00656136?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00656136's enrollment target sits among peer trials
585 651st of 2000 higher than 1,349 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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