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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 585 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00656136
The ClinicalTrials.gov registry entry for NCT00656136 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 585 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00656136 reports 0 study locations.
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.
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