Status:
COMPLETED
BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with pathologic confirmation of NSCLC Stage III-B (with pleural effusion) or Stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum-based.
- Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
- Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as \>20 mm using conventional techniques or \>10 mm with spiral CT scan
- Male and female patients age \>18 years
- Life expectancy of at least three (3) months
- Written informed consent that is consistent with ICH-GCP guidelines
- Exclusion criteria:
- Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1
- Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
- Active brain metastases
- Significant or recent acute gastrointestinal disorders with diarrhea
- Patients who have any other life-threatening illness or organ system dysfunction,
- Other malignancies diagnosed within the past five (5) years
- Radiotherapy within the past 2 weeks prior to treatment
- History of clinically significant or uncontrolled cardiac disease
- Adequate ANC and platelet count
- Adequate liver and kidney function
- Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
585 Patients enrolled
Trial Details
Trial ID
NCT00656136
Start Date
April 1 2008
End Date
October 1 2013
Last Update
July 26 2016
Active Locations (90)
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1
1200.23.038 Boehringer Ingelheim Investigational Site
Kingman, Arizona, United States
2
1200.23.046 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas, United States
3
1200.23.027 Boehringer Ingelheim Investigational Site
Anaheim, California, United States
4
1200.23.028 Boehringer Ingelheim Investigational Site
Berkeley, California, United States