BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
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|ClinicalTrials.gov Identifier: NCT00656136|
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : November 27, 2013
Last Update Posted : July 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: placebo Drug: BIBW 2992||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||585 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Study Start Date :||April 2008|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
Placebo Comparator: Placebo
Patients receive placebo once daily
Patients receive placebo once daily
Experimental: BIBW 2992
Patients receive BIBW 2992 tablets once daily
Drug: BIBW 2992
Patients receive afatinib tablets once daily, and can reduce dose for adverse event management. Afatinib is given once daily, continuously until disease progression or unacceptable toxicity.
- Overall Survival [ Time Frame: 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.
- Progression-free Survival (PFS) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656136
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|