NCT04222972

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

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• RET-fusion Non Small Cell Lung Cancer
• Lung Neoplasm
• Carcinoma, Non-Small-Cell Lung
• Respiratory Tract Neoplasms
• Thoracic Neoplasms
• Neoplasms by Site
• Neoplasms
• Lung Diseases
• Respiratory Tract Disease
• Carcinoma, Bronchogenic
• Bronchial Diseases
• Head and Neck Neoplasms
• Adenocarcinoma
• Carcinoma
• Neoplasms by Histologic Type
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Nerve Tissue

Interventions

Type	Name	Description
DRUG	Pralsetinib	Administered orally
DRUG	Carboplatin	Administered IV
DRUG	Cisplatin	Administered IV
DRUG	Pemetrexed	Administered IV
DRUG	Pembrolizumab	Administered IV
DRUG	Gemcitabine	Administered IV
DRUG	Paclitaxel	Administered IV
DRUG	Nab-Paclitaxel	Administered IV

Timeline

• Start date: 2020-07-24
• Primary completion: 2025-01-27
• Completion: 2025-01-27
• First posted: 2020-01-10
• Last updated: 2026-03-05
• Results posted: 2026-03-05

Locations

74 sites across 22 countries: Argentina, Australia, Belgium, Brazil, Costa Rica, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Panama, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study