Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 718
Healthy volunteers: no

Brief summary:
The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained.

Detailed description:

Arms:
arm 1: nintedanib (BIBF1120) along with standard therapy of pemetrexed arm 2: Pemetrexed standard therapy arm 3: nintedanib (BIBF1120) monotherapy only for patients who discontinue pemetrexed arm 4: pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo arm 5: placebo monotherapy only for patients who discontinue pemetrexed

Interventions: intervention 1: Nintedanib (BIBF1120) intervention 2: Pemetrexed intervention 3: pemetrexed intervention 4: B12 intervention 5: dexamethasone (or corticosteroid equivalent) intervention 6: placebo intervention 7: dexamethasone (or corticosteroid equivalent) intervention 8: B12 intervention 9: Folic Acid intervention 10: B12 intervention 11: dexamethasone (or corticosteroid equivalent) intervention 12: Folic Acid intervention 13: placebo intervention 14: Folic Acid intervention 15: Nintedanib (BIBF1120) intervention 16: Pemetrexed
Intervention descriptions: intervention 1: starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid. intervention 2: 500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle. intervention 3: 500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle. intervention 4: 1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed intervention 5: 4 mg PO bid the day before, the day of and the day after each pemetrexed infusion intervention 6: starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid. intervention 7: 4 mg PO bid the day before, the day of and the day after each pemetrexed infusion intervention 8: 1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed intervention 9: 400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed. intervention 10: 1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed intervention 11: 4 mg PO bid the day before, the day of and the day after each pemetrexed infusion intervention 12: 400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed. intervention 13: starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid. intervention 14: 400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed. intervention 15: starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid. intervention 16: 500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

Protocol document: