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)
Overview
- Phase
- Phase 3
- Intervention
- placebo
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 585
- Locations
- 90
- Primary Endpoint
- Overall Survival
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Patients receive placebo once daily
Intervention: placebo
BIBW 2992
Patients receive BIBW 2992 tablets once daily
Intervention: BIBW 2992
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Progression-free Survival (PFS)(From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months)
- Objective Response Rate (OR)(From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months)