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CheckMate 057: Nivolumab vs Docetaxel in Non-Squamous NSCLC
NCT01673867Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2012
- Primary completion
- Feb 2015
- Countries
- 22
- Sponsor
- Bristol Myers Squibb
- Modality
- Monoclonal Antibodies
- Drugs
- nivolumab
- Conditions
- Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)
01
Overview
Phase 3, randomised, open-label trial of nivolumab in Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC) (2 arms), sponsored by Bristol Myers Squibb. Primary endpoint: Overall Survival. Started Nov 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Nivolumab
Nivolumab 3 mg/kg IV every 2 weeks
Docetaxel
Docetaxel 75 mg/m2 IV every 3 weeks (Crossover to Nivolumab allowed upon progression)
03
Who it enrols
Adult patients with stage IIIB/IV or recurrent non-squamous NSCLC who have progressed on or after one prior platinum-based chemotherapy regimen. Patients must have measurable disease, ECOG PS 0-1, and available tumor tissue for biomarker analysis. Patients with untreated CNS metastases, active autoimmune disease, or prior treatment with checkpoint inhibitors or docetaxel are excluded.
04
Endpoints
Primary
Overall Survival
Secondary
Objective Response Rate
Time To Objective Response
Duration of Objective Response
Progression-Free Survival
Percentage of Participants Experiencing Disease-Related Symptom Improvement
Overall Survival by PD-L1 Expression
Objective Response Rate by PD-L1 Expression
05
Results
Primary endpoints met
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