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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.
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
Conditions
Interventions
TAS6417
Oral tablets.
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