Phase II Avastin Trial for Stage IIIB/IV NSCLC

Sponsor
Pharmatech
Study ID
NCT00766246
Phase
PHASE2
Status
Terminated

Conditions

  • Non-small Cell Lung Cancer Stage IIIB
  • Non-small Cell Lung Cancer Stage IV

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    15 mg/kg administered in 21 day cycles on day 1 of each cycle for first-line and maintenance
  • docetaxel — DRUG
    75 mg/m2 administered in 21-day cycles on day 1 of each cycle for first line treatment
  • carboplatin — DRUG
    AUC=6 administered in 21-day cycles on day 1 of each cycle for first-line treatment

Study Details

This is a randomized, open-label, multicenter study in 160 patients in first line treatment and 114 in second line treatment with advanced or metastatic NSCLC (Stage IIIB/IV).

Key Dates

First listed
Oct 3, 2008
Start date
Oct 31, 2008
Status verified
Apr 2016
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012

Study Design

Enrollment
125 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: First-line
    Carboplatin, docetaxel, bevacizumab Open-label, single arm with treatment period up to 6 cycles. Patients completing a total of 2 to 6 cycles of first-line without disease progression will be eligible for maintenance.
  • Experimental: Maintenance
    Bevacizumab Open-label, single arm with treatment period up to 18 cycles.

Primary Outcome Measure

Progression-free survival (PFS) of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV NSCLC [ Time Frame: Duration of study ]

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