A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Summary

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.

Timeline

Start

2020-07-24

Primary completion

2025-01-27

Completion

2025-01-27

Outcome

Met primary endpoint

Stopped: “Early termination of the study resulted from organizational and commercial decisions that led to the discontinuation of pralsetinib's global marketing and development in all territories (excluding US and Greater China).”

registry analysis (superiority test); Arm A: Treatment Period- SOC vs Arm B: Treatment Period- Pralsetinib; p = 0.0027; Hazard Ratio (HR) 0.59 (95% CI 0.42 to 0.84); Log Rank NCT04222972 ↗

release “In the Phase 3 AcceleRET clinical trial, pralsetinib met the primary progression-free survival (PFS) endpoint” rigel.com ↗

Drugs

Indications