BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
Public ClinicalTrials.gov record NCT00656136. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00656136
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 585 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2008 (Type not available)
- Primary completion
- Oct 2013 (Actual)
- Completion
- Oct 2013 (Actual)
- Last update posted
- Jul 26, 2016
2008 – 2013
United States locations
- U.S. sites
- 14
- U.S. states
- 7
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1200.23.038 Boehringer Ingelheim Investigational Site | Kingman | Arizona | — | — |
| 1200.23.046 Boehringer Ingelheim Investigational Site | Fayetteville | Arkansas | — | — |
| 1200.23.027 Boehringer Ingelheim Investigational Site | Anaheim | California | — | — |
| 1200.23.028 Boehringer Ingelheim Investigational Site | Berkeley | California | — | — |
| 1200.23.029 Boehringer Ingelheim Investigational Site | Modesto | California | — | — |
| 1200.23.045 Boehringer Ingelheim Investigational Site | Montebello | California | — | — |
| 1200.23.009 Boehringer Ingelheim Investigational Site | Orange | California | — | — |
| 1200.23.026 Boehringer Ingelheim Investigational Site | Palm Springs | California | — | — |
| 1200.23.024 Boehringer Ingelheim Investigational Site | North Miami Beach | Florida | — | — |
| 1200.23.020 Boehringer Ingelheim Investigational Site | New York | New York | — | — |
| 1200.23.013 Boehringer Ingelheim Investigational Site | Valhalla | New York | — | — |
| 1200.23.056 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | — | — |
| 1200.23.039 Boehringer Ingelheim Investigational Site | Renton | Washington | — | — |
| 1200.23.050 Boehringer Ingelheim Investigational Site | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 76 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00656136, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2016 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00656136 live on ClinicalTrials.gov.