A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)

Sponsor
Genentech, Inc.
Study ID
NCT00318136
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3
  • Carboplatin — DRUG
    Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
  • Paclitaxel — DRUG
    Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles

Study Details

This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.

Key Dates

First listed
Apr 26, 2006
Start date
Sep 30, 2005
Status verified
May 2010
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treated with Bevacizumab

Primary Outcome Measure

Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ]

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