CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
bevacizumab [Avastin] +3 moredrug
Likely dose
bevacizumab [Avastin] 7.5mg/kgfrom 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/NCT01077713
NCT01077713Phase 2Completed

Randomised Phase II Trial of Bevacizumab (AVASTIN®) in Combination With Gemcitabine or Attenuated Doses of Cisplatin and Gemcitabine as First-line Treatment of Elderly Patients With Advanced Non-squamous Non-small Cell Lung Cancer - EAGLES

Hoffmann-La Roche·interventional·Posted Mar 1, 2010·Updated Oct 8, 2015

In Brief

A Phase 2 clinical trial evaluating bevacizumab [Avastin], cisplatin, and 1 other intervention for Non-Squamous Non-Small Cell Lung Cancer. Completed, enrolled 86 participants across 26 sites.

Detailed Summary

This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 16.3 years ago

Interventions

bevacizumab [Avastin]drug

7.5mg/kg iv on day 1 of each 3 week cycle

cisplatindrug

60mg/m2 on day 1 of each 3 week cycle

gemcitabinedrug

1200mg/m2 on days 1-8 of each 3 week cycle

gemcitabinedrug

1000mg/m2 on days 1-8 of each 3 week cycle