Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief summary:
The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy.

The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.

Detailed description:

Arms:
arm 1: BI 6727 plus 500 mg/\^m2 pemetrexed i.v. on day 1 of 21 day cycle arm 2: 500 mg/m\^2 i.v. on day 1 of a 21 day cycle

Interventions: intervention 1: pemetrexed intervention 2: pemetrexed intervention 3: BI 6727
Intervention descriptions: intervention 1: 500 mg/m\^2 i.v. on day 1 of 21 day cycle intervention 2: 500 mg/m\^2 i.v. on day 1 of 21 day cycle intervention 3: BI 6727 i.v. on day 1 of a 21 day cycle

Protocol document: