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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

Phase 3
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

Inclusion Criteria

Inclusion criteria:

1. 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.

2. Progressive disease following at least 12 weeks of treatment with erlotinib
(Tarceva®) or gefitinib (Iressa®)

3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2

4. 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

5. Male and female patients age >18 years

6. Life expectancy of at least three (3) months

7. Written informed consent that is consistent with ICH-GCP guidelines

Exclusion criteria:

1. Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1

2. Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance
non-cancer therapy) or immunotherapy within the past 4 weeks

3. Active brain metastases

4. Significant or recent acute gastrointestinal disorders with diarrhea

5. Patients who have any other life-threatening illness or organ system dysfunction,

6. Other malignancies diagnosed within the past five (5) years

7. Radiotherapy within the past 2 weeks prior to treatment

8. History of clinically significant or uncontrolled cardiac disease

9. Adequate ANC and platelet count

10. Adequate liver and kidney function

11. Patients with any serious active infection including known HIV, active hepatitis B or
active hepatitis C

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Overall survival time (OS)

Outcome Time Frame:

9 months

Safety Issue:


Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals


Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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