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RECRUITING
NCT07128199
PHASE3

A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

Sponsor: Taiho Oncology, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).

Official title: A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Versus Placebo in Early Stage NSCLC Patients With Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2025-12-22

Completion Date

2032-10-01

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

TAS6417

Oral tablets.

DRUG

Zipalertinib Matching-placebo

Oral tablets.

Locations (253)

Alaska Oncology and Hematology

Anchorage, Alaska, United States

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, United States

City of Hope Comprehensive Cancer Center Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Scripps Clinic Torrey Pines

La Jolla, California, United States

Kaiser Permanente - Vallejo Medical Center

Vallejo, California, United States

Georgetown University School of Medicine

Washington D.C., District of Columbia, United States

D&H Cancer Research Center - Margate

Margate, Florida, United States

Alpha Oncology Research

Orange City, Florida, United States

City of Hope - Atlanta

Newnan, Georgia, United States

University of Illinois Medical Center

Chicago, Illinois, United States

Profound Research LLC at Michigan Hematology and Oncology Consultants

Dearborn, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center - Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, United States

Memorial Sloan Kettering Cancer Center - Westchester

East White Plains, New York, United States

Long Island Jewish Medical Center

Lake Success, New York, United States

Perlmutter Cancer Center - 34th Street

New York, New York, United States

Memorial Sloan Kettering Cancer Center - New York

New York, New York, United States

Memorial Sloan Kettering Cancer Center - Nassau

Uniondale, New York, United States

Atrium Health Wake Forest Baptist - Comprehensive Cancer Center

Charlotte, North Carolina, United States

Durham Veterans Affairs Health Care System

Durham, North Carolina, United States

Gabrail Cancer and Research Center

Canton, Ohio, United States

Gibbs Cancer Center and Research Institute Spartanburg

Spartanburg, South Carolina, United States

Virginia Cancer Specialists - Arlington Office

Arlington, Virginia, United States

Virginia Cancer Specialists - Fairfax Office

Fairfax, Virginia, United States

Virginia Cancer Specialists - Bristow Office

Manassas, Virginia, United States

Virginia Cancer Specialists - Reston

Reston, Virginia, United States

Virginia Cancer Specialists - Woodbridge Office

Woodbridge, Virginia, United States

Instituto Argentino de Diagnóstico y Tratamiento

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Centro de Investigación Pergamino SA

Pergamino, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

CEMAIC - Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

Córdoba, Córdoba Province, Argentina

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, Australia

GenesisCare - North Shore

St Leonards, New South Wales, Australia

Saint John of God - Subiaco Hospital

Subiaco, Western Australia, Australia

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Algemeen Ziekenhuis Sint-Maarten

Mechelen, Antwerpen, Belgium

Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg

Leuven, Flemish Brabant, Belgium

NOHC - Núcleo de Oncologia e Hematologia do Ceará - José Lourenço

Fortaleza, Ceará, Brazil

Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Centro de Pesquisas Clínicas Em Oncologia - CPCO

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Hospital Santa Rita

Vitória, Espírito Santo, Brazil

Núcleo de Oncologia da Bahia Ondina - NOB

Salvador, Estado de Bahia, Brazil

Oncoclinicas Oncovida - Brasilia

Brasília, Federal District, Brazil

Cetus Oncologia - Unidade Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Cenantron Centro Avançado de Tratamento Oncológico

Belo Horizonte, Minas Gerais, Brazil

Centro Integrado de Oncologia de Curitiba (CIONC)

Curitiba, Paraná, Brazil

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Centro de Pesquisa Vencer e Oncoclínica - Teresina

Teresina, Piauí, Brazil

Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro

Botafogo, Rio de Janeiro, Brazil

Liga Contra o Câncer - Centro Avançado de Oncologia

Natal, Rio Grande do Norte, Brazil

Clínica Viver

Centro Santa Maria, Rio Grande do Sul, Brazil

Hospital Bruno Born

Lajeado, Rio Grande do Sul, Brazil

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Mãe de Deus - Centro Integrado de Oncologia

Porto Alegre, Rio Grande do Sul, Brazil

Grupo ELORA

Florianópolis, Santa Catarina, Brazil

CHO Centro - Centro de Hematologia e Oncologia de Joinville

Joinville, Santa Catarina, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor

Barretos, São Paulo, Brazil

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

A Beneficência Portuguesa de São Paulo

São Paulo, São Paulo, Brazil

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, São Paulo, Brazil

Instituto de Oncologia de Sorocaba

Sorocaba, São Paulo, Brazil

Cross Cancer Institute

Edmonton, Alberta, Canada

William Osler Health System - Brampton Civic Hospital

Brampton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Sciences Centre - Bayview Campus

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hôpital Saint-André

Bordeaux, Aquitane, France

Hôpital Louis Pradel

Bron, Auvergne-Rhône-Alpes, France

Hôpital de la Croix Rousse

Lyon, Auvergne-Rhône-Alpes, France

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, France

L'Hôpital Nord-Ouest (HNO) - Villefranche-sur-Saône

Villefranche-de-Rouergue, Aveyron, France

Hôpital Côte De Nacre

Caen, Basse-Normandie, France

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Hôpital Emile Muller

Mulhouse, Grand Est, France

Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, France

Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

Saint-Herblain, Loire-Atlantique, France

Centre Hospitalier Universitaire d'Angers

Angers, Maine-et-Loire, France

CHU d Angers

Angers, Maine-et-Loire, France

Institut de Cancérologie de l'Ouest - Angers

Angers, Maine-et-Loire, France

CHU de Nimes - Caremeau Nord

Nîmes, Occitanie, France

Hôpital Universitaire Pitié Salpêtrière

Paris, Paris, France

Centre Hospitalier Le Mans

Le Mans, Pays de la Loire Region, France

Hopital Prive du Confluet

Nantes, Pays de la Loire Region, France

Hôpital Privé du Confluent

Nantes, Pays de la Loire Region, France

Hopital Nord Ouest

Gleizé, Rhône, France

Gustave Roussy

Villejuif, Val-De-Marne, France

Hôpital Ambroise-Paré

Boulogne-Billancourt, Île-de-France Region, France

Centre Hospitalier Intercommunal de Créteil

Créteil, Île-de-France Region, France

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, France

Hôpital Bichat - Claude-Bernard

Paris, Île-de-France Region, France

SLK-Kliniken - Fachklinik Löwenstein

Löwenstein, Baden-Wurttemberg, Germany

Krankenhaus Nordwest

Frankfurt am Main, Hesse, Germany

Universitätsklinikum Gießen und Marburg - Gießen

Giessen, Hesse, Germany

Kliniken der Stadt Köln

Cologne, North Rhine-Westphalia, Germany

And 153 more locations on ClinicalTrials.gov