Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT00806819
- Lead Sponsor
- Boehringer Ingelheim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 718
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nintedanib (BIBF1120) plus pemetrexed Nintedanib (BIBF1120) nintedanib (BIBF1120) along with standard therapy of pemetrexed nintedanib (BIBF1120) plus pemetrexed B12 nintedanib (BIBF1120) along with standard therapy of pemetrexed nintedanib (BIBF1120) plus pemetrexed dexamethasone (or corticosteroid equivalent) nintedanib (BIBF1120) along with standard therapy of pemetrexed nintedanib (BIBF1120) plus pemetrexed Folic Acid nintedanib (BIBF1120) along with standard therapy of pemetrexed nintedanib (BIBF1120) plus pemetrexed pemetrexed nintedanib (BIBF1120) along with standard therapy of pemetrexed Placebo plus pemetrexed placebo Pemetrexed standard therapy Placebo plus pemetrexed dexamethasone (or corticosteroid equivalent) Pemetrexed standard therapy Placebo plus pemetrexed B12 Pemetrexed standard therapy Placebo plus pemetrexed Folic Acid Pemetrexed standard therapy nintedanib (BIBF1120) monotherapy Nintedanib (BIBF1120) nintedanib (BIBF1120) monotherapy only for patients who discontinue pemetrexed pemetrexed monotherapy dexamethasone (or corticosteroid equivalent) pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo pemetrexed monotherapy Folic Acid pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo placebo monotherapy placebo placebo monotherapy only for patients who discontinue pemetrexed pemetrexed monotherapy B12 pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo Placebo plus pemetrexed pemetrexed Pemetrexed standard therapy pemetrexed monotherapy pemetrexed pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) as Assessed by Central Independent Review 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 Outcome Measures
Name Time Method Overall Survival (Key Secondary Endpoint) From randomisation until data cut-off (15 February 2013), Up to 30 months Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
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 Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.
Incidence and Intensity of Adverse Events From the first drug administration until 28 days after the last drug administration, up to 36 months Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.
Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint.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 was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
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 Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
Objective Tumor Response From randomisation until data cut-off (15 February 2013), Up to 30 months Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator
Duration of Confirmed Objective Tumour Response From randomisation until data cut-off (15 February 2013), Up to 30 months The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator.Clinical Improvement. From randomisation until data cut-off (15 February 2013), Up to 30 months Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.Disease Control From randomisation until data cut-off (15 February 2013), Up to 30 months Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.
This endpoint was analysed based on the central independent reviewer as well as the investigator.Quality of Life (QoL) From randomisation until data cut-off (15 February 2013), Up to 30 months QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.Time to Confirmed Objective Tumour Response From randomisation until data cut-off (15 February 2013), Up to 30 months Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator.Duration of Disease Control From randomisation until data cut-off (15 February 2013), Up to 30 months The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
This endpoint was analysed based on the central independent reviewer as well as the investigator.Change From Baseline in Tumour Size From randomisation until data cut-off (15 February 2013), Up to 30 months Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator.
Trial Locations
- Locations (1)
Boehringer Ingelheim Investigational Site
🇺🇦Vinnytsia, Ukraine