CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 303 enrolled
Drug / intervention
bevacizumab [Avastin] +2 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/NCT00700180
NCT00700180Phase 2Completed

A Randomized, Open-label Study to Explore the Correlation of Biomarkers With Response Rate in Chemo-naive Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer Who Receive Treatment With Avastin in Addition to Carboplatin-based Chemotherapy

Hoffmann-La Roche·interventional·Posted Jun 18, 2008·Updated Sep 25, 2014

In Brief

A Phase 2 clinical trial evaluating bevacizumab [Avastin] and Carboplatin-based chemotherapy for Non-Small Cell Lung Cancer. Completed, enrolled 303 participants across 59 sites in 16 countries.

Detailed Summary

This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Italy, Netherlands, Poland, Russia, Spain, Taiwan, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.0 years ago

Interventions

bevacizumab [Avastin]drug

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

bevacizumab [Avastin]drug

15mg/kg iv on day 1 of each 3 week cycle

Carboplatin-based chemotherapydrug

As prescribed