Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 585
Healthy volunteers: no

Brief summary:
This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed.

The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment.

Patients enrolled into the trial will be treated and followed until death or lost to follow-up.

Detailed description:

Arms:
arm 1: Patients receive placebo once daily arm 2: Patients receive BIBW 2992 tablets once daily

Interventions: intervention 1: placebo intervention 2: BIBW 2992
Intervention descriptions: intervention 1: Patients receive placebo once daily intervention 2: Patients receive afatinib tablets once daily, and can reduce dose for adverse event management. Afatinib is given once daily, continuously until disease progression or unacceptable toxicity.

Protocol document: