A Study of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (SABRE-L)

Sponsor
Genentech, Inc.
Study ID
NCT00434226
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle
  • sunitinib — DRUG
    25 mg/day for 2 weeks, followed by 1 week of rest
  • carboplatin — DRUG
    On the first day of each cycle for 4 cycles
  • paclitaxel — DRUG
    On the first day of each cycle for 4 cycles

Study Details

This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced, recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with pleural effusions, Stage IV, or recurrent).

Key Dates

First listed
Feb 13, 2007
Start date
Mar 31, 2007
Status verified
Jul 2009
Primary completion
Apr 30, 2008

Study Design

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

Arms

  • Experimental: Bevacizumab + Carboplatin/Paclitaxel + Sunitinib
  • Placebo Comparator: Bevacizumab + Carboplatin/Paclitaxel

Primary Outcome Measure

Best Response [ Time Frame: From randomization until disease progression/recurrence ]

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