A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology.
- Registration Number
- NCT01346540
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The LUME-Lung3 study is in 2 parts:
Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and cisplatin.
Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2 previous courses of the chemotherapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIBF 1120 BIBF 1120 VEGF inhibitor Placebo Placebo BIBF 1120 placebo
- Primary Outcome Measures
Name Time Method Number of Participants With Dose Limiting Toxicities (DLTs) During First Cycle for the Determination of the Maximum Tolerated Dose (MTD) Up to 21 days from first drug administration The following drug-related adverse events (AEs) qualified as a DLT: Non-hematological toxicity - Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3 events excluding transient electrolyte abnormality, hyperuricemia and isolated elevation of gamma-glutamyl trans-peptidase. Gastrointestinal AEs (nausea, vomiting, diarrhoea, abdominal pain) or hypertension of CTCAE Grade ≥3 despite optimal supportive care/intervention. Alanine aminotransferase and or Aspartate aminotransferase elevation of CTCAE Grade ≥3. Haematological toxicity - Uncomplicated CTCAE Grade 4 neutropenia (that was not associated with fever of ≥38.5° Celsius) for \>7 days (except during Cycle 1). CTCAE Grade 4 febrile neutropenia associated with fever ≥38.5º Celsius. A decrease in platelet levels to CTCAE Grade 4 or CTCAE Grade 3 associated with bleeding or requiring transfusion. The inability to resume nintedanib dosing within 14 days of stopping due to a drug-related AE was also considered a DLT.
Maximum Tolerated Dose (MTD) of Nintedanib Added to Cisplatin/Gemcitabine Based on the Occurrence of DLTs During Treatment Cycle 1. Up to 21 days from first drug administration The MTD was defined as the dose of nintedanib administered with gemcitabine/cisplatin at which no more than 1 of 6 patients experienced DLT (or one dose tier below that dose at which 2 or more of 6 patients experienced DLT) during the first 21-day treatment cycle. Any DLTs experienced after the start of the second treatment period were considered separately.
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00 From the first drug administration until 28 days after last study drug administration, up to 804 days Incidence of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00 with grade 1-5.
Trial Locations
- Locations (7)
1199.82.3102 Boehringer Ingelheim Investigational Site
🇳🇱Maastricht, Netherlands
1199.82.3406 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1199.82.3410 Boehringer Ingelheim Investigational Site
🇪🇸Málaga, Spain
1199.82.3401 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1199.82.39004 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1199.82.4401 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1199.82.4402 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom