LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
1. pathologically confirmed diagnosis of stage IIIB or stage IV adenocarcinoma of the
2. EGFR(Epidermal Growth Factor Receptor) mutation detected by central laboratory
analysis of tumor biopsy material
3. Measurable disease according to RECIST1.1
4. ECOG(Eastern Cooperative Oncology Group) score of 0 or 1.
5. Age>=18 years
6. life expectancy of at least three months
7. Written informed consent that is consistent with ICH-GCP guidelines.
1. Prior chemotherapy for relapsed and/or metastatic NSCLC.
2. Prior treatment with EGFR targeting small molecules or antibodies.
3. Radiotherapy or surgery(other than biopsy) within 4 weeks prior to randomization
4. Active brain metastases
5. Any other current malignancy or malignancy diagnosed within the past 5 years
6. Known pre-existing interstitial lung disease
7. Significant or recent acute gastrointestinal disorders with diarrhoea as a a major
8. History or presence of clinically relevant cardiovascular abnormalities
9. Cardiac left ventricular function with resting ejection fraction of less than 50%.
10. Any other concomitant serious 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.
11. Absolute neutrophil count(ANC)<1500/mm3
12. Platelet count<100,000/mm3
13. Creatinine clearance<60ml/min or serum creatinine>1.5 times ULN(upper limiter of
14. Bilirubin>1.5 times ULN
15. AST(Aspartate Amino Transferase) or ALT(Alanine Amino Transferase) > 3 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 of breast-feeding
18. Patients unable to comply with the protocol
19. Active hepatitis B infection, active hepatitis C infection or known HIV(Human
Immunodeficiency Virus) 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
22. Any contraindications for therapy with gemcitabine/cisplatin
23. Known hypersensitivity to BIBW2992 or the excipient of any of the trial drugs
24. Use of any investigational drug within 4 weeks of randomization.