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Pragmatica-Lung: Ramucirumab + Pembrolizumab vs Standard of Care in Advanced NSCLC
NCT05633602Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2023
- Primary completion
- Nov 2025
- Countries
- 1
- Sponsor
- SWOG Cancer Research Network
- Modality
- Immune Checkpoint Inhibitors, Antibody Conjugates, Recombinant Proteins and Enzymes
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised, open-label trial in non-small cell lung cancer (NSCLC) comparing Standard of Care Chemotherapy with Ramucirumab + Pembrolizumab (2 arms). Primary endpoint: Overall Survival at 3 years. Started Mar 2023; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard of Care Chemotherapy
Patients receive chemotherapy per standard of care.
Ramucirumab + Pembrolizumab
Patients receive ramucirumab IV and pembrolizumab IV.
03
Who it enrols
Adults with stage IV or recurrent NSCLC who have experienced disease progression after prior treatment with both platinum-based chemotherapy and at least one line of anti-PD-1 or anti-PD-L1 therapy. Patients with actionable mutations must have received appropriate targeted therapy.
04
Endpoints
Primary
Overall Survival
Secondary
Incidence of high-grade (>= grade 3) adverse events
05
Results
Not all primary endpoints met
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