Study: NCT00806819

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nintedanib (BIBF1120)
Description: 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 type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pemetrexed
Description: 500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: pemetrexed
Description: 500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: B12
Description: 1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: dexamethasone (or corticosteroid equivalent)
Description: 4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: 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 type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: dexamethasone (or corticosteroid equivalent)
Description: 4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: B12
Description: 1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Folic Acid
Description: 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 type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: B12
Description: 1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone (or corticosteroid equivalent)
Description: 4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Folic Acid
Description: 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 type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: 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 type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Folic Acid
Description: 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 type: DRUG
Group type: EXPERIMENTAL
Intervention: Nintedanib (BIBF1120)
Description: 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 type: DRUG
Group type: EXPERIMENTAL
Intervention: Pemetrexed
Description: 500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.