At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 636 enrolled
Drug / intervention
bevacizumab +2 moredrug
Likely dose
Bevacizumab 15 mg/kg intravenously every 3 weeks + erlotinib 150 mg orally dailyAI-extracted
Key inclusion· 6
- ✓Histologically or cytologically confirmed non-small cell lung cancer
- ✓Disease progression during or after first-line chemotherapy or chemoradiotherapy
- ✓ECOG performance status 0, 1, or 2
- ✓Age ≥18 years
Key exclusion· 10
- ✕Squamous cell carcinoma histology
- ✕Prior EGFR pathway inhibitors or anti-angiogenesis agents
- ✕Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior to randomization
- ✕Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4 weeks of Day 0
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy
In Brief
A Phase 3 clinical trial evaluating bevacizumab, erlotinib HCl, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 636 participants across 4 sites.
Detailed Summary
This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedAug 2005
Primary CompletionJul 2008
Study CompletionDec 2019
TodayJul 2026
First PostedAug 16, 2005
Enrollment StartJun 8, 2005
Primary CompletionJul 15, 2008
Study CompletionDec 23, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.9 years ago
Interventions
bevacizumabdrug
intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
erlotinib HCldrug
oral erlotinib HCl 150 mg/day orally
placebodrug
intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle