CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 485 enrolled
Drug / intervention
Bevacizumab +3 moredrug
Likely dose
Bevacizumab 15 milligramsfrom 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.

Search/NCT01351415
NCT01351415Phase 3Completed
CompareCT.gov

An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

Hoffmann-La Roche·interventional·Posted May 10, 2011·Updated Sep 18, 2017

In Brief

A Phase 3 clinical trial evaluating Bevacizumab, Docetaxel, and 2 other interventions for Non-Squamous Non-Small Cell Lung Cancer. Completed, enrolled 485 participants across 179 sites in 18 countries.

Detailed Summary

This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Squamous Non-Small Cell Lung Cancer
CountriesArgentina, Austria, Belgium, Brazil, Denmark, France, Germany, Greece, Italy, Japan, Lebanon, Mexico, Netherlands, Oman, Slovakia, Spain, United Arab Emirates, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2011
Enrollment StartJun 25, 2011
Primary CompletionJun 25, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 15.1 years ago

Interventions

Bevacizumabdrug

Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.

Docetaxeldrug

Docetaxel 60 or 75 milligram per meter square (mg/m\^2) on Day 1 every 21 days.

Erlotinibdrug

Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.

Pemetrexeddrug

Pemetrexed 500 mg/m\^2 IV over 10 minutes on Day 1 every 21 days.