Adenocarcinoma of the lung MedDRA version: 9.1 Level: LLT Classification code 10001164 Term: Adenocarcinoma lung stage III MedDRA version: 9.1 Level: LLT Classification code 10001165 Term: Adenocarcinoma lung stage IV
Conditions
Interventions
Product Code: BIBW2992
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BIBW2992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Code: BIB
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology. 2. EGFR mutation detected by central laboratory analysis of tumour biopsy material. 3. Measurable disease according to RECIST 1.1. 4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 5. Age = 18 years. 6. Life expectancy of at least three (3) months. 7. Written informed consent that is consistent with ICH-GCP guidelines. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation. 2. Prior treatment with EGFR targeting small molecules or antibodies. 3. Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation. 4. Active brain metastases (defined as stable for 1.5 times upper limit of normal. 14. Bilirubin > 1.5 times upper limit of normal. 15. Aspartate amino transferase (AST) or alanine amino transferase (ALT) > three times the upper limit of normal (ULN) (if related to liver metastases > five times ULN). 16. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial. 17. Pregnancy or breast-feeding. 18. Patients unable to comply with the protocol. 19. Active hepatitis B infection, active hepatitis C infection or known HIV carrier. 20. Known or suspected active drug or alcohol abuse. 21. Requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2.2. 22. Any contraindications for therapy with pemetrexed, cisplatin or dexamethasone. 23. Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs. 24. Use of any investigational drug within 4 weeks of randomisation (unless a longer time period is required by local regulations).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival (PFS), determined by RECIST 1.1.;Secondary Objective: -Overall survival -Objective response (CR, PR) according to RECIST 1.1 -Disease control (CR, PR, SD) according to RECIST 1.1 -Deterioration of body weight and ECOG performance status -Health-related quality of life (HRQOL) -Pharmacokinetics of BIBW 2992 -Safety of BIBW 2992 as indicated by intensity and incidence of adverse events, graded according to US NCI CTCAE Version 3.0;Primary end point(s): Progression free survival, as determined by RECIST 1.1. | — |
Countries
Austria, Belgium, France, Germany, Hungary, Ireland, Italy, United Kingdom
Outcome results
None listed