LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy
LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy
This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.
Inclusion criteria:
Exclusion criteria:
Prior treatment with Epidermal Growth Factor Receptor (EGFR) directed small molecules or antibodies.
Radiotherapy within 4 weeks prior to randomization.
Active brain metastases .
Any other current malignancy or malignancy diagnosed within the past three (3) years (other than basal-cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer).
Known pre-existing interstitial lung disease.
Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom
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.
Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
Female patients of childbearing potential (see Section 4.2.3.3) who:
Active hepatitis B infection (defined as presence of Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
Known or suspected active drug or alcohol abuse in the opinion of the investigator.
Any contraindications for therapy with afatinib or erlotinib.
Known hypersensitivity to erlotinib, afatinib or the excipients of any of the trial drugs.
Major surgery within 4 weeks of starting study treatment.
Prior participation in an afatinib clinical study, even if not assigned to afatinib.
Use of any investigational drug within 4 weeks of randomisation (unless a longer time period is required by local regulations or by the guidelines for the investigational product).
Patients without Progression of their lung cancer.
DuBois, Pennsylvania 15801, United States
Ciudad Autonoma de Bs As, C1426ANZ, Argentina
Providencia, Santiago, 7501088, Chile
Recoleta, Santiago de Chile, 8420383, Chile
Essen, 45147, Germany
Neo Faliro, Athens, 18547, Greece
Farkasgyepü, 8582, Hungary