At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
BIBF 1120 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating BIBF 1120 and Placebo for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 16 participants across 7 sites in 4 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesItaly, Netherlands, Spain, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedMay 2011
Primary CompletionApr 2013
Study CompletionJan 2017
TodayJul 2026
First PostedMay 3, 2011
Enrollment StartApr 14, 2011
Primary CompletionApr 25, 2013
Study CompletionJan 17, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 15.2 years ago
Interventions
BIBF 1120drug
VEGF inhibitor
Placebodrug
BIBF 1120 placebo