Trial intelligence / Profile preview

BRAIN: Avastin in NSCLC with Untreated Brain Metastases

NCT00800202Phase 2

Key facts

Status: Completed
Start: Apr 2009
Primary completion: Oct 2012
Countries: 1
Sponsor: Roche
Modality: Monoclonal Antibodies

Drugs: bevacizumab
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, open-label trial of bevacizumab in non-small cell lung cancer (NSCLC) (2 cohorts), sponsored by Roche. Primary endpoints: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 months, Percentage of Participants With Disease Progression or Death up to 18 months and 1 more. Started Apr 2009; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Cohort 1 (First-line)
Avastin + Paclitaxel + Carboplatin
Cohort 2 (Second-line)
Avastin + Tarceva

Who it enrols

Adult patients with stage IV non-squamous NSCLC and asymptomatic, untreated brain metastasis. Excludes patients with history of migraine, epilepsy, or previous treatment for brain metastasis.

Endpoints

Primary

Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death6 months
Percentage of Participants With Disease Progression or Deathup to 18 months
Time to Disease Progression or Deathup to 18 months

Secondary

Percentage of Participants Who Diedup to 18 months
Probability of Being Alive18 months
Time to Deathup to 18 months
Best Overall Response (CR or PR)up to 18 months

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