Multicenter, Randomized, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Pemetrexed Therapy Compared to Placebo Plus Standard Pemetrexed Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 718
- Locations
- 1
- Primary Endpoint
- Progression Free Survival (PFS) as Assessed by Central Independent Review
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
nintedanib (BIBF1120) plus pemetrexed
nintedanib (BIBF1120) along with standard therapy of pemetrexed
Intervention: Nintedanib (BIBF1120) (Drug)
nintedanib (BIBF1120) plus pemetrexed
nintedanib (BIBF1120) along with standard therapy of pemetrexed
Intervention: B12 (Drug)
nintedanib (BIBF1120) plus pemetrexed
nintedanib (BIBF1120) along with standard therapy of pemetrexed
Intervention: dexamethasone (or corticosteroid equivalent) (Drug)
nintedanib (BIBF1120) plus pemetrexed
nintedanib (BIBF1120) along with standard therapy of pemetrexed
Intervention: Folic Acid (Drug)
nintedanib (BIBF1120) plus pemetrexed
nintedanib (BIBF1120) along with standard therapy of pemetrexed
Intervention: pemetrexed (Drug)
Placebo plus pemetrexed
Pemetrexed standard therapy
Intervention: pemetrexed (Drug)
Placebo plus pemetrexed
Pemetrexed standard therapy
Intervention: dexamethasone (or corticosteroid equivalent) (Drug)
Placebo plus pemetrexed
Pemetrexed standard therapy
Intervention: B12 (Drug)
Placebo plus pemetrexed
Pemetrexed standard therapy
Intervention: placebo (Drug)
Placebo plus pemetrexed
Pemetrexed standard therapy
Intervention: Folic Acid (Drug)
nintedanib (BIBF1120) monotherapy
nintedanib (BIBF1120) monotherapy only for patients who discontinue pemetrexed
Intervention: Nintedanib (BIBF1120) (Drug)
pemetrexed monotherapy
pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo
Intervention: pemetrexed (Drug)
pemetrexed monotherapy
pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo
Intervention: B12 (Drug)
pemetrexed monotherapy
pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo
Intervention: dexamethasone (or corticosteroid equivalent) (Drug)
pemetrexed monotherapy
pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo
Intervention: Folic Acid (Drug)
placebo monotherapy
placebo monotherapy only for patients who discontinue pemetrexed
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Progression Free Survival (PFS) as Assessed by Central Independent Review
Time Frame: From randomisation until cut-off date 9 July 2012
Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Secondary Outcomes
- Overall Survival (Key Secondary Endpoint)(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide(Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3)
- Incidence and Intensity of Adverse Events(From the first drug administration until 28 days after the last drug administration, up to 36 months)
- Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Objective Tumor Response(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Duration of Confirmed Objective Tumour Response(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Clinical Improvement.(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Quality of Life (QoL)(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Time to Confirmed Objective Tumour Response(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Disease Control(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Duration of Disease Control(From randomisation until data cut-off (15 February 2013), Up to 30 months)
- Change From Baseline in Tumour Size(From randomisation until data cut-off (15 February 2013), Up to 30 months)