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Expanded Access Program BIBW 2992 for Non Small Cell Lung Cancer ( NSCLC) Last Line Treatment

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

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Trial Information

Expanded Access Program BIBW 2992 for Non Small Cell Lung Cancer ( NSCLC) Last Line Treatment

Inclusion Criteria:

Patients with pathologic confirmation of adenocarcinoma of the lung Stage IIIB with
pleural effusion or Stage IV

Exclusion Criteria:

1 Brain metastases which are symptomatic; patients with treated, asymptomatic brain
metastases are eligible with stable brain disease for at least four 4 weeks without the
requirement for steroids or anti epileptic therapy 2) Significant or recent acute
gastrointestinal disorders with diarrhea as a major symptom as judged by the investigator.

3) Patients who have any other life-threatening illness or organ system dysfunction, which
in the opinion of the investigator, would either compromise patient safety or interfere
with the evaluation of the safety of the test drug 4) History of cardiac disease that is
clinically significant, as judged by the investigator or uncontrolled cardiac disease
(including congestive heart failure, angina, myocardial infarction, arrhythmia, including
New York Heart Association (NYHA) functional classification of 3) 5) Cardiac left
ventricular function with resting ejection fraction of less than 50% 6) Bilirubin 1.5 mg /
dl (26 mol / L, SI unit equivalent) 7) Aspartate amino transferase (AST) or alanine amino
transferase (ALT) three times the upper limit of normal (if related to liver metastases
five times the upper limit of normal) 8) Serum creatinine 1.5 times of the upper normal
limit or calculated/measured creatine clearance 45ml/min 9) Women of child-bearing
potential or men who are able to father a child unwilling to use a medically acceptable
method of contraception during the trial 10) Pregnancy or breast feeding 11) Patients
unable to comply with the protocol 12) Patients with known HIV, active hepatitis B or
active hepatitis C 13) Pre-existing Interstitial Lung Disease (ILD) 14) Requirement for
treatment with any of the prohibited concomitant medications listed in Section

15) Patients already pre-treated with BIBW 2992

Type of Study:

Expanded Access

Study Design:


Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals


Australia: Dept of Health and Ageing Therapeutic Goods Admin

Study ID:




Start Date:

November 2010

Completion Date:

Related Keywords:

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