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Pralsetinib vs Standard of Care in RET Fusion-Positive Metastatic NSCLC
NCT04222972Phase 3
Key facts
- Status
- Terminated
- Start
- Jul 2020
- Primary completion
- Jan 2025
- Countries
- 22
- Sponsor
- Roche
- Modality
- Small Molecules
- Drugs
- pralsetinib
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised, open-label trial in non-small cell lung cancer (NSCLC) comparing Pralsetinib with Standard of Care (2 arms). Primary endpoint: Progression-Free Survival at 50 months. Started Jul 2020; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Pralsetinib
Experimental Arm receiving oral Pralsetinib
Standard of Care
Active Comparator Arm receiving platinum-based chemotherapy with or without pembrolizumab
03
Who it enrols
Treatment-naive patients with RET fusion-positive metastatic NSCLC and ECOG PS 0-1.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Objective Response Rate
Overall Survival
Adverse Events
Eastern Cooperative Oncology Group Performance Status
Duration of Response
Clinical Benefit Rate
Disease Control Rate
05
Results
Primary endpoints met
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