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NADIM: Neoadjuvant Nivolumab and Chemotherapy in Stage IIIA NSCLC
NCT03081689Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2017
- Primary completion
- Sep 2023
- Countries
- 1
- Sponsor
- Fundación GECP
- Modality
- Monoclonal Antibodies
- Drugs
- nivolumab
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, open-label, single-arm trial of nivolumab in non-small cell lung cancer (NSCLC), sponsored by Fundación GECP. Primary endpoint: Progression-Free Survival at 24 months. Started Apr 2017; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Experimental Arm
Neoadjuvant Nivolumab + Chemo followed by Surgery and Adjuvant Nivolumab
03
Who it enrols
Adults with histologically documented resectable stage IIIA (N2) NSCLC, ECOG 0-1, excluding those with EGFR or ALK mutations.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Pathological Response Rate
Safety
Feasibility
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