Phase 3
N=713
Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT00806819 ↗Enrolled (actual)
713
Serious AEs
31.4%
Results posted
Nov 2014
Primary outcome: Primary: Progression Free Survival (PFS) as Assessed by Central Independent Review — 4.4; 3.6 months — p=0.0435
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nintedanib (BIBF1120) (Drug); Pemetrexed (Drug); B12 (Drug); dexamethasone (or corticosteroid equivalent) (Drug); placebo (Drug); Folic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) as Assessed by Central Independent Review |
4.4; 3.6 | 0.0435 sig |
| SECONDARY Overall Survival (Key Secondary Endpoint) |
12.0; 12.7 | 0.8940 |
| SECONDARY Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review |
4.4; 3.4 | 0.0506 |
| SECONDARY Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator |
5.3; 4.3 | 0.0865 |
| SECONDARY Objective Tumor Response |
9.1; 8.3; 15.0; 13.3 | 0.7279 |
| SECONDARY Duration of Confirmed Objective Tumour Response |
6.9; 4.4; 6.5; 7.2 | — |
| SECONDARY Time to Confirmed Objective Tumour Response |
2.6; 2.7; 2.6; 2.8 | — |
| SECONDARY Disease Control |
60.9; 53.3; 66.0; 60.3 | 0.0387 sig |
| SECONDARY Duration of Disease Control |
7.4; 6.8; 6.9; 6.8 | — |
| SECONDARY Change From Baseline in Tumour Size |
-10.10; -7.53; -15.60; -11.28 | 0.1558 |
| SECONDARY Clinical Improvement. |
7.2; 7.5 | 0.5068 |
| SECONDARY Quality of Life (QoL) |
6.0; 4.3; 2.4; 2.0; 2.8; 2.7 | 0.1181 |
| SECONDARY Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide |
0.0883; 0.103; 0.131; 0.151; 1.40; 1.72 | — |
| SECONDARY Incidence and Intensity of Adverse Events |
4.9; 9.2; 22.2; 30.5; 46.1; 34.5 | — |
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.
Eligibility Criteria
Inclusion criteria
- Male or female patient aged 18 years or older.
- Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or recurrent non small cell lung cancer (NSCLC) (non squamous histologies)
- Relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy).
- At least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT.
- Life expectancy of at least three months.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- Patient has given written informed consent which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation.
Exclusion criteria
- Previous therapy with other vascular endothelial growth factor (VEGF) inhibitors (other than bevacizumab) or pemetrexed for treatment of NSCLC
- Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
- Chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of extremities) within the past four weeks prior to treatment with the trial drug, i.e., the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be four weeks
- Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several days
- Active brain metastases (e.g. stable for 10 %) within the past 6 weeks prior to treatment in the present trial
- Current peripheral neuropathy greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except due to trauma
- Pre-existing ascites (abdominal fluid collection) and/or clinically significant pleural effusion ( fluid collection between the lung and chest wall)
- Major injuries and/or surgery within the past ten days prior to start of study drug
- Incomplete wound healing
- Active or chronic hepatitis C and/or B infection Additional exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT00806819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.