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.
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|ClinicalTrials.gov Identifier: NCT01346540|
Recruitment Status : Completed
First Posted : May 3, 2011
Results First Posted : September 10, 2018
Last Update Posted : September 10, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: BIBF 1120 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||LUME-Lung 3: 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|
|Actual Study Start Date :||April 14, 2011|
|Actual Primary Completion Date :||April 25, 2013|
|Actual Study Completion Date :||January 17, 2017|
Experimental: BIBF 1120
Drug: BIBF 1120
Placebo Comparator: Placebo
BIBF 1120 placebo
BIBF 1120 placebo
- Number of Participants With Dose Limiting Toxicities (DLTs) During First Cycle for the Determination of the Maximum Tolerated Dose (MTD) [ Time Frame: 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. [ Time Frame: 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.
- Incidence of Adverse Events (AEs) According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346540
|1199.82.39004 Boehringer Ingelheim Investigational Site|
|1199.82.3102 Boehringer Ingelheim Investigational Site|
|1199.82.3401 Boehringer Ingelheim Investigational Site|
|1199.82.3406 Boehringer Ingelheim Investigational Site|
|1199.82.3410 Boehringer Ingelheim Investigational Site|
|1199.82.4401 Boehringer Ingelheim Investigational Site|
|London, United Kingdom|
|1199.82.4402 Boehringer Ingelheim Investigational Site|
|Manchester, United Kingdom|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|