A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT04222972 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 223
Last updated 2026-03-05
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
- DRUG
-
Pralsetinib
Administered orally
- DRUG
-
Administered IV
- DRUG
-
Administered IV
- DRUG
-
Pemetrexed
Administered IV
- DRUG
-
Administered IV
- DRUG
-
Administered IV
- DRUG
-
Administered IV
- DRUG
-
Administered IV
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-24
- Primary Completion
- 2025-01-27
- Completion
- 2025-01-27
- FDA Drug
- Yes
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
Study Locations
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