BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
- Registration Number
- NCT00656136
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 585
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIBW 2992 BIBW 2992 Patients receive BIBW 2992 tablets once daily Placebo placebo Patients receive placebo once daily
- Primary Outcome Measures
Name Time Method Overall Survival From randomization until death or the last patient out date, an average of 12 months 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 be still alive. Final analysis data cut-off date was 04 October 2013.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).
Objective Response Rate (OR) From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0.
Related Research Topics
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Trial Locations
- Locations (90)
1200.23.038 Boehringer Ingelheim Investigational Site
🇺🇸Kingman, Arizona, United States
1200.23.046 Boehringer Ingelheim Investigational Site
🇺🇸Fayetteville, Arkansas, United States
1200.23.027 Boehringer Ingelheim Investigational Site
🇺🇸Anaheim, California, United States
1200.23.028 Boehringer Ingelheim Investigational Site
🇺🇸Berkeley, California, United States
1200.23.029 Boehringer Ingelheim Investigational Site
🇺🇸Modesto, California, United States
1200.23.045 Boehringer Ingelheim Investigational Site
🇺🇸Montebello, California, United States
1200.23.009 Boehringer Ingelheim Investigational Site
🇺🇸Orange, California, United States
1200.23.026 Boehringer Ingelheim Investigational Site
🇺🇸Palm Springs, California, United States
1200.23.024 Boehringer Ingelheim Investigational Site
🇺🇸North Miami Beach, Florida, United States
1200.23.020 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
Scroll for more (80 remaining)1200.23.038 Boehringer Ingelheim Investigational Site🇺🇸Kingman, Arizona, United States