Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 74
Healthy volunteers: no

Brief summary:
The objective of the Phase I step is to estimate the MTD at a dose level up to 50 mg/day (i.e., overseas recommended Phase II dose) in patients with advanced NSCLC and to determine the recommended dose for the Phase II step.

The objective of the Phase II step is to estimate the efficacy of BIBW 2992 monotherapy in patients with first generation EGFR-TKI-resistant advanced NSCLC at the recommended dose determined in the Phase I step.

Detailed description:

Arms:
arm 1: Phase I step: Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally. Escalating doses of BIBW 2992 starting at 20mg daily. arm 2: Phase II step: Patients start continuous once daily oral treatment of BIBW 2992 at high dose, until progression or undue Adverse Events (AEs) develop. Patients can be dose-reduced up to two times if needed after temporary discontinuation of treatment due to drug-related AEs.

Interventions: intervention 1: BIBW 2992 MA2 40mg/day intervention 2: BIBW 2992 MA2 50mg/day intervention 3: BIBW 2992 MA2 20mg/day intervention 4: BIBW 2992 QD
Intervention descriptions: intervention 1: Phase I step: Increased dose cohorts from low dose to MTD intervention 2: Phase I step: Increased dose cohorts from low dose to MTD intervention 3: Phase I step: Increased dose cohorts from low dose to MTD intervention 4: Phase II step: This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs.

Protocol document: