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

TERMINATEDPHASE3

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

NCT04222972•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant has pathologically confirmed, definitively diagnosed, locally advanced (not able to be treated with surgery or radiotherapy) or metastatic NSCLC and has not been treated with systemic anticancer therapy for metastatic disease.
•Participant must have a documented RET-fusion
•Participant has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment.
•Participant has an ECOG Performance Status of 0 or 1.
•Participant should not have received any prior anticancer therapy for metastatic disease.
•* Participants can have received previous anticancer therapy (except a selective RET inhibitor) in the neoadjuvant or adjuvant setting but must have experienced an interval of at least ≥ 6 months from completion of therapy to recurrence.
•* Participants that received previous immune checkpoint inhibitors in the adjuvant or consolidation following chemoradiation are not allowed to receive pembrolizumab if randomized in Arm B
•Participant is an appropriate candidate for and agrees to receive 1 of the Investigator choice platinum-based chemotherapy regimens if randomized to Arm B.
•For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception.
•For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm.

Exclusion Criteria

•Participant's tumor has any additional known primary driver alterations other than RET, such as targetable mutations of EGFR, ALK, ROS1, MET, and BRAF. Investigators should discuss enrollment with Sponsor designee regarding co-mutations.
•Participant previously received treatment with a selective RET inhibitor.
•Participant received radiotherapy or radiosurgery to any site within 14 days before randomization or more than 30 Gy of radiotherapy to the lung in the 6 months before randomization.
•Participant with a history of pneumonitis within the last 12 months.
•Participant has CNS metastases or a primary CNS tumor that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. If a participant requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1.
•Participant has had a history of another primary malignancy that has been diagnosed or required therapy within the past 3 years prior to randomization.

Locations (74)

Hospital Britanico

Buenos Aires, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Royal North Shore Hospital

St Leonards, New South Wales, Australia

UZ Antwerpen

Edegem, Belgium

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital A. C. Camargo

São Paulo, São Paulo, Brazil

Clinica CIMCA

San José, Costa Rica

Institut Bergonie CLCC Bordeaux

Bordeaux, France

Hôpital Ambroise Paré - Boulogne-Billancourt

Boulogne-Billancourt, France

Hôpital Louis Pradel, Hospices Civils de Lyon

Bron, France

Key Dates

Start Date

July 24, 2020

Primary Completion Date

January 27, 2025

Completion Date

January 27, 2025

Last Updated

March 5, 2026

Enrollment

223

ACTUAL participants

Conditions

RET-fusion Non Small Cell Lung CancerLung NeoplasmCarcinoma, Non-Small-Cell LungRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseaseCarcinoma, BronchogenicBronchial DiseasesHead and Neck NeoplasmsAdenocarcinomaCarcinomaNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve Tissue

Interventions

Pralsetinib

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Pemetrexed

DRUG

Pembrolizumab

DRUG

Gemcitabine

DRUG

Paclitaxel

DRUG

Nab-Paclitaxel

DRUG

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

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RECRUITINGPHASE2

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

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