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Panitumumab with Paclitaxel and Carboplatin in Advanced NSCLC
NCT00034346Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2002
- Sponsor
- Amgen
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- panitumumab
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, open-label, single-arm trial of panitumumab in non-small cell lung cancer (NSCLC), sponsored by Amgen. Primary endpoint: Time to Disease Progression. Started Jan 2002; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
ABX-EGF + Paclitaxel + Carboplatin
Panitumumab in combination with Paclitaxel and Carboplatin.
03
Who it enrols
Patients with advanced NSCLC (Stage IIIB/IV) over-expressing EGFR, no prior systemic chemotherapy for NSCLC, and adequate organ function.
04
Endpoints
Primary
Time to Disease Progression
Secondary
Best Overall Response Rate
Response Rate at Week 5
Survival Time
Progression Free Survival
Rate of Progressive Disease at Week 11
Incidence of Adverse Events
Pharmacokinetics of Panitumumab
Quality of Life
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