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Bevacizumab in extensive-stage small cell lung cancer
NCT00403403Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2007
- Primary completion
- Feb 2009
- Sponsor
- Genentech
- Modality
- Monoclonal Antibodies
- Drugs
- bevacizumab
- Conditions
- small cell lung cancer (SCLC)
01
Overview
Phase 2, randomised, double-blind trial in small cell lung cancer (SCLC) comparing Placebo+Chemotherapy with Bevacizumab+Chemotherapy (2 arms). Primary endpoint: Progression-free Survival at 2 years. Started Mar 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo+Chemotherapy
Placebo + Cisplatin/Carboplatin + Etoposide followed by Placebo maintenance
Bevacizumab+Chemotherapy
Bevacizumab + Cisplatin/Carboplatin + Etoposide followed by Bevacizumab maintenance
03
Who it enrols
Patients with histologically or cytologically documented extensive-stage small cell lung cancer, ECOG performance status 0-2, and adequate organ function. Excludes patients with prior systemic therapy for SCLC, active malignancies, or significant cardiovascular or bleeding risks.
04
Endpoints
Primary
Progression-free Survival
Secondary
Overall Survival
Objective Response Rate
Duration of Response
05
Results
Primary endpoints met
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