Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Nintedanib (BIBF1120)

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.

DRUG

Pemetrexed

500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

DRUG

pemetrexed

500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

DRUG

B12

1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

DRUG

dexamethasone (or corticosteroid equivalent)

4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

DRUG

placebo

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.

DRUG

dexamethasone (or corticosteroid equivalent)

4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

DRUG

B12

1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

DRUG

Folic Acid

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.

DRUG

B12

1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed

DRUG

dexamethasone (or corticosteroid equivalent)

4 mg PO bid the day before, the day of and the day after each pemetrexed infusion

DRUG

Folic Acid

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.

DRUG

placebo

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.

DRUG

Folic Acid

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.

DRUG

Nintedanib (BIBF1120)

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.

DRUG

Pemetrexed

500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle.

Sponsors & Collaborators

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-12-31

Primary Completion

2011-06-30

Completion

2015-12-31

Countries

• United States
• Argentina
• Australia
• Bosnia and Herzegovina
• Brazil
• Canada
• Chile
• Colombia
• Ecuador
• Germany
• Hong Kong
• Hungary
• Ireland
• Latvia
• Malaysia
• Mexico
• Moldova
• Netherlands
• New Zealand
• North Macedonia
• Panama
• Peru
• Philippines
• Poland
• Romania
• Serbia
• South Korea
• Sweden
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine

Study Locations