At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 671 enrolled
Drug / intervention
BI 695502 +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.
A Multicenter, Randomized, Double-blind Phase III Trial to Evaluate Efficacy and Safety of BI 695502 Plus Chemotherapy Versus Avastin® Plus Chemotherapy in Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating BI 695502 and Avastin for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 671 participants across 189 sites in 28 countries.
Detailed Summary
The objective of this phase III trial is to establish statistical equivalence in terms of efficacy (best overall response rate \[ORR\], proportion of patients with complete response \[CR\] plus partial response \[PR\]) until 18 weeks of first-line treatment with BI 695502 plus chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with either BI 695502 or Avastin®.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesArgentina, Brazil, Bulgaria, Chile, Croatia, Egypt, Germany, Greece, Hungary, Italy, Japan, Malaysia, Mexico, Philippines, Poland, Portugal, Romania, Russia, Serbia, South Africa, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartJul 2015
Primary CompletionJun 2017
Study CompletionNov 2018
TodayJul 2026
First PostedOct 23, 2014
Enrollment StartJul 8, 2015
Primary CompletionJun 30, 2017
Study CompletionNov 16, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.7 years ago
Interventions
BI 695502drug
Avastindrug