A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients With Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)

Status: Recruiting
Location: See all (209) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.

• Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendment (CLIA) certified (United States \[US\]) or accredited (outside of the US) local laboratory, defined as either one of the following EGFRmt:

‣ exon20 insertion mutations (ex20ins) or

⁃ other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)

• Magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain done prior to surgery. Participants in whom this was not done prior to surgery may still be enrolled if appropriate imaging (i.e., MRI or CT of the brain) is performed prior to randomization.

• Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor. Resection may be accomplished by open thoracotomy or video associated thoracic surgery (VATS) techniques.

• Classified post-operatively as either Stage IB, IIA, IIB, or IIIA according to the tumor nodes metastasis (TNM) staging system for lung cancer (American Joint Committee on Cancer \[AJCC\] 9th edition).

• Complete recovery from surgery at the time of randomization.

• Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1.

• Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers.

Locations
United States
Alaska
Alaska Oncology and Hematology
NOT_YET_RECRUITING
Anchorage
California
City of Hope Comprehensive Cancer Center - Duarte
NOT_YET_RECRUITING
Duarte
Washington, D.c.
Georgetown University School of Medicine
NOT_YET_RECRUITING
Washington D.c.
Florida
D&H Cancer Research Center - Margate
NOT_YET_RECRUITING
Margate
Alpha Oncology Research
NOT_YET_RECRUITING
Orange City
Illinois
University of Illinois Medical Center
NOT_YET_RECRUITING
Chicago
Michigan
Profound Research LLC at Michigan Hematology and Oncology Consultants
RECRUITING
Dearborn
Henry Ford Health System
NOT_YET_RECRUITING
Detroit
North Carolina
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
NOT_YET_RECRUITING
Charlotte
New York
Memorial Sloan Kettering Cancer Center - New York
NOT_YET_RECRUITING
New York
Perlmutter Cancer Center - 34th Street
NOT_YET_RECRUITING
New York
Ohio
Gabrail Cancer and Research Center
RECRUITING
Canton
Virginia
Virginia Cancer Specialists - Fairfax Office
NOT_YET_RECRUITING
Fairfax
Other Locations
Argentina
Instituto Argentino de Diagnóstico y Tratamiento
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
CEMAIC - Centro de Especialidades Médicas Ambulatorias e Investigación Clínica
NOT_YET_RECRUITING
Córdoba
Centro de Investigación Pergamino SA
NOT_YET_RECRUITING
Pergamino
Hospital Universitario Austral
NOT_YET_RECRUITING
Pilar
Australia
Bankstown-Lidcombe Hospital
NOT_YET_RECRUITING
Bankstown
GenesisCare - North Shore
NOT_YET_RECRUITING
St Leonards
Saint John of God - Subiaco Hospital
NOT_YET_RECRUITING
Subiaco
Belgium
Universitair Ziekenhuis Antwerpen
NOT_YET_RECRUITING
Edegem
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
NOT_YET_RECRUITING
Leuven
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor
NOT_YET_RECRUITING
Barretos
Cenantron Centro Avançado de Tratamento Oncológico
NOT_YET_RECRUITING
Belo Horizonte
Cetus Oncologia - Unidade Belo Horizonte
NOT_YET_RECRUITING
Belo Horizonte
Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro
NOT_YET_RECRUITING
Botafogo
Oncoclinicas Oncovida - Brasilia
NOT_YET_RECRUITING
Brasília
Centro de Pesquisas Clínicas Em Oncologia - CPCO
NOT_YET_RECRUITING
Cachoeiro De Itapemirim
Clínica Viver
NOT_YET_RECRUITING
Centro Santa Maria
Centro Integrado de Oncologia de Curitiba (CIONC)
NOT_YET_RECRUITING
Curitiba
Grupo ELORA
NOT_YET_RECRUITING
Florianópolis
Centro Regional Integrado de Oncologia
NOT_YET_RECRUITING
Fortaleza
NOHC - Núcleo de Oncologia e Hematologia do Ceará - José Lourenço
NOT_YET_RECRUITING
Fortaleza
Hospital Amaral Carvalho
NOT_YET_RECRUITING
Jaú
CHO Centro - Centro de Hematologia e Oncologia de Joinville
NOT_YET_RECRUITING
Joinville
Hospital Bruno Born
NOT_YET_RECRUITING
Lajeado
Liga Contra o Câncer - Centro Avançado de Oncologia
NOT_YET_RECRUITING
Natal
Hospital São Vicente de Paulo
NOT_YET_RECRUITING
Passo Fundo
Hospital Mãe de Deus - Centro Integrado de Oncologia
NOT_YET_RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Instituto de Medicina Integral Professor Fernando Figueira
NOT_YET_RECRUITING
Recife
Núcleo de Oncologia da Bahia Ondina - NOB
NOT_YET_RECRUITING
Salvador
A Beneficência Portuguesa de São Paulo
NOT_YET_RECRUITING
São Paulo
Instituto de Assistência Médica ao Servidor Público Estadual
NOT_YET_RECRUITING
São Paulo
Instituto de Oncologia de Sorocaba
NOT_YET_RECRUITING
Sorocaba
Centro de Pesquisa Vencer e Oncoclínica - Teresina
NOT_YET_RECRUITING
Teresina
Hospital Santa Rita
NOT_YET_RECRUITING
Vitória
Canada
London Health Sciences Centre
NOT_YET_RECRUITING
London
William Osler Health System - Brampton Civic Hospital
NOT_YET_RECRUITING
Montreal
France
Centre Hospitalier Universitaire d'Angers
NOT_YET_RECRUITING
Angers
Institut de Cancérologie de l'Ouest - Angers
NOT_YET_RECRUITING
Angers
Hôpital Saint-André
NOT_YET_RECRUITING
Bordeaux
Hôpital Ambroise-Paré
NOT_YET_RECRUITING
Boulogne-billancourt
Hôpital Côte De Nacre
NOT_YET_RECRUITING
Caen
Centre Hospitalier Intercommunal de Créteil
NOT_YET_RECRUITING
Créteil
Centre Hospitalier Le Mans
NOT_YET_RECRUITING
Le Mans
Centre Léon Bérard
NOT_YET_RECRUITING
Lyon
Hôpital Emile Muller
NOT_YET_RECRUITING
Mulhouse
Hôpital Privé du Confluent
NOT_YET_RECRUITING
Nantes
Centre Hospitalier Universitaire de Nîmes
NOT_YET_RECRUITING
Nîmes
Groupe Hospitalier Paris Saint-Joseph
NOT_YET_RECRUITING
Paris
Hôpital Bichat - Claude-Bernard
NOT_YET_RECRUITING
Paris
Centre Hospitalier Lyon-Sud
NOT_YET_RECRUITING
Pierre-bénite
Hôpital Pontchaillou
NOT_YET_RECRUITING
Rennes
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
NOT_YET_RECRUITING
Saint-herblain
L'Hôpital Nord-Ouest (HNO) - Villefranche-sur-Saône
NOT_YET_RECRUITING
Villefranche-de-rouergue
Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
Kliniken der Stadt Köln
NOT_YET_RECRUITING
Cologne
Krankenhaus Nordwest
NOT_YET_RECRUITING
Frankfurt Am Main
Universitätsklinikum Gießen und Marburg - Gießen
NOT_YET_RECRUITING
Giessen
SLK-Kliniken - Fachklinik Löwenstein
NOT_YET_RECRUITING
Löwenstein
Greece
BioClinic Thessaloniki
NOT_YET_RECRUITING
Athens
General Hospital for Thoracic Diseases Sotiria
NOT_YET_RECRUITING
Athens
Metaxa Cancer Hospital of Piraeus
NOT_YET_RECRUITING
Athens
Saint Savvas Anticancer - Oncological Hospital of Athens
NOT_YET_RECRUITING
Athens
Interbalkan Medical Center of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Humanity & Health Clinical Trial Centre
NOT_YET_RECRUITING
Hong Kong
Queen Mary Hospital - Hong Kong
NOT_YET_RECRUITING
Hong Kong
Princess Margaret Hospital
NOT_YET_RECRUITING
Kowloon
Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria
NOT_YET_RECRUITING
Alessandria
Azienda Ospedaliero Universitaria Delle Marche
NOT_YET_RECRUITING
Ancona
Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
NOT_YET_RECRUITING
Bergamo
Humanitas Gavazzeni
NOT_YET_RECRUITING
Bergamo
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
NOT_YET_RECRUITING
Bologna
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
NOT_YET_RECRUITING
Candiolo
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico
NOT_YET_RECRUITING
Catania
Azienda Socio Sanitaria Territoriale (ASST) di Bergamo Ovest
NOT_YET_RECRUITING
Legnano
Azienda Unità Sanitaria Locale Toscana Nord Ovest
NOT_YET_RECRUITING
Livorno
Ospedale Santa Maria delle Croci di Ravenna
NOT_YET_RECRUITING
Lugo
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST
NOT_YET_RECRUITING
Meldola
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING
Milan
Fondazione IRCCS - Istituto Nazionale dei Tumori
NOT_YET_RECRUITING
Milan
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Istituto Europeo di Oncologia
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero - Universitaria di Modena
NOT_YET_RECRUITING
Modena
Ospedale del Mare
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
NOT_YET_RECRUITING
Orbassano
Fondazione IRCCS Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
NOT_YET_RECRUITING
Peschiera Del Garda
Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata
NOT_YET_RECRUITING
Roma
Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
NOT_YET_RECRUITING
Siena
Azienda Ospedaliera Universitaria Integrata Verona
NOT_YET_RECRUITING
Verona
Japan
Hyogo Cancer Center
NOT_YET_RECRUITING
Akashi
National Hospital Organization Kyushu Cancer Center
NOT_YET_RECRUITING
Fukuoka
Kansai Medical University Hospital
NOT_YET_RECRUITING
Hirakata
Hiroshima University Hospital
NOT_YET_RECRUITING
Hiroshima
National Cancer Center Hospital East
NOT_YET_RECRUITING
Kashiwa-shi
Kobe University Hospital
NOT_YET_RECRUITING
Kobe
Cancer Institute Hospital of JFCR
RECRUITING
Koto
Kurume University Hospital
NOT_YET_RECRUITING
Kurume-shi
Nagasaki University Hospital
NOT_YET_RECRUITING
Nagasaki
Aichi Cancer Center
NOT_YET_RECRUITING
Nagoya
Okayama University Hospital
NOT_YET_RECRUITING
Okayama
Osaka City General Hospital
RECRUITING
Osaka
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
NOT_YET_RECRUITING
Osaka
Kindai University Hospital
NOT_YET_RECRUITING
Osakasayama-shi
Tohoku University Hospital
NOT_YET_RECRUITING
Sendai
Shizuoka Cancer Center
NOT_YET_RECRUITING
Sunto-gun
Kanagawa Cancer Center
NOT_YET_RECRUITING
Yokohama
Malaysia
Hospital Raja Perempuan Zainab II
NOT_YET_RECRUITING
Kota Bharu
Hospital Kuala Lumpur
NOT_YET_RECRUITING
Kuala Lumpur
Hospital Picaso
NOT_YET_RECRUITING
Petaling Jaya
Hospital Pulau Pinang
NOT_YET_RECRUITING
Pulau Pinang
Sunway Medical Centre
NOT_YET_RECRUITING
Selangor Darul Ehsan
Mexico
Preparaciones Oncológicas S.C.
NOT_YET_RECRUITING
León
Centro Oncológico Alianza XXI
NOT_YET_RECRUITING
Mexico City
Clínica Integral Internacional de Oncología S de RL de CV
NOT_YET_RECRUITING
Mirador
Netherlands
Ziekenhuis St Jansdal Harderwijk
NOT_YET_RECRUITING
Harderwijk
Leids Universitair Medisch Centrum (LUMC)
NOT_YET_RECRUITING
Leiden
Radboud Universitair Medisch Centrum
NOT_YET_RECRUITING
Nijmegen
Peru
Hospital Nacional Arzobispo Loayza
NOT_YET_RECRUITING
Lima Cercado
IPOR - Instituto Peruano de Oncología & Radioterapia - Sede Principal
NOT_YET_RECRUITING
San Isidro
Detecta Clínica
NOT_YET_RECRUITING
Surquillo
Poland
Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej
NOT_YET_RECRUITING
Biała Podlaska
Przychodnia Lekarska KOMED Roman Karaszewski
NOT_YET_RECRUITING
Konin
Warmińsko-mazurskie Centrum Chorób Płuc w Olsztynie
NOT_YET_RECRUITING
Olsztyn
Mruk-Med I Sp. z o.o.
NOT_YET_RECRUITING
Rzeszów
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
NOT_YET_RECRUITING
Wroclaw
Republic of Korea
Chungbuk National University Hospital
NOT_YET_RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital
NOT_YET_RECRUITING
Daegu
Kyungpook National University Chilgok Hospital
NOT_YET_RECRUITING
Daegu
National Cancer Center - Korea
NOT_YET_RECRUITING
Goyang-si
Chonnam National University Hwasun Hospital
NOT_YET_RECRUITING
Hwasun-gun
Inha University Hospital
NOT_YET_RECRUITING
Incheon
Jeonbuk National University Hospital
NOT_YET_RECRUITING
Jeonju
Gyeongsang National University Hospital
NOT_YET_RECRUITING
Jinju
Kosin University Gospel Hospital
NOT_YET_RECRUITING
Pusan
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam-si
Hanyang University Hospital
NOT_YET_RECRUITING
Seoul
Konkuk University Medical Center
NOT_YET_RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea - Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Ajou University Hospital
NOT_YET_RECRUITING
Suwon
Catholic University of Korea St. Vincent's Hospital
NOT_YET_RECRUITING
Suwon
Pusan National University Yangsan Hospital
NOT_YET_RECRUITING
Yangsan
Romania
Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu
NOT_YET_RECRUITING
Bucharest
Monza Oncology Day Hospital
NOT_YET_RECRUITING
Bucharest
Centrul de Radioterapie Amethyst Cluj
NOT_YET_RECRUITING
Floreşti
Ovidius Clinical Hospital
NOT_YET_RECRUITING
Ovidiu
Clinica MC Gral Ploiesti
NOT_YET_RECRUITING
Ploieşti
Spitalul Județean de Urgență Satu Mare
NOT_YET_RECRUITING
Satu Mare
Oncocenter - Oncologie Clinica
NOT_YET_RECRUITING
Timișoara
Singapore
National Cancer Centre Singapore
NOT_YET_RECRUITING
Singapore
Tan Tock Seng Hospital
NOT_YET_RECRUITING
Singapore
Spain
Institut Català d'Oncologia Badalona
NOT_YET_RECRUITING
Badalona
Hospital Universitari Vall d'Hebrón
NOT_YET_RECRUITING
Barcelona
Instituto Oncológico Dr Rosell
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Clínico San Cecilio PTS
NOT_YET_RECRUITING
Granada
Complejo Hospitalario Universitario Insular Materno Infantil
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Lucus Augusti
NOT_YET_RECRUITING
Lugo
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
NOT_YET_RECRUITING
Madrid
MD Anderson Cancer Center Madrid
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
NOT_YET_RECRUITING
Majadahonda
Hospital Quirónsalud Málaga
NOT_YET_RECRUITING
Málaga
Hospital Universitario Son Espases
NOT_YET_RECRUITING
Palma De Mallorca
Hospital Universitari Sant Joan de Reus
NOT_YET_RECRUITING
Reus
Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITING
Seville
Hospital Universitari i Politècnic La Fe
NOT_YET_RECRUITING
Valencia
Thailand
Chulabhorn Hospital
NOT_YET_RECRUITING
Bang Kapi
Navamindradhiraj University - Faculty of Medicine Vajira Hospital
NOT_YET_RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital
NOT_YET_RECRUITING
Bangkoknoi
Songklanagarind Hospital
NOT_YET_RECRUITING
Hat Yai
Lampang Cancer Hospital
NOT_YET_RECRUITING
Muang
Turkey
Medical Park Seyhan Hastanesi
NOT_YET_RECRUITING
Adana
T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi
NOT_YET_RECRUITING
Adana
Liv Hospital Ankara
NOT_YET_RECRUITING
Ankara
Memorial Ankara Hastanesi
NOT_YET_RECRUITING
Ankara
VM Medical Park Samsun Hastanesi
NOT_YET_RECRUITING
Atakum
Memorial Bahçelievler Hospital
NOT_YET_RECRUITING
Bahçelievler
Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
NOT_YET_RECRUITING
Edirne
İstinye Üniversite Hastanesi Liv Hospital Bahcesehir
NOT_YET_RECRUITING
Esenyurt
Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi
NOT_YET_RECRUITING
Etlik
Ozel Gaziantep Medical Point Hastanesi
NOT_YET_RECRUITING
Gaziantep
T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
NOT_YET_RECRUITING
Istanbul
Izmir Ekonomi Universitesi Medical Point Hastanesi
NOT_YET_RECRUITING
Izmir
İ.A.Ü. VM Medical Park Florya Hastanesi
NOT_YET_RECRUITING
Küçükçekmece
Gaziantep Universitesi - Şahinbey Araştırma ve Uygulama Hastanesi
NOT_YET_RECRUITING
Şehitkamil
Dicle Üniversitesi Tıp Fakültesi
NOT_YET_RECRUITING
Sur
Medicana International Izmir Hastanesi
NOT_YET_RECRUITING
Turgutlu
Başkent Üniversitesi Adana Dr Turgut Noyan Uygulama ve Araştirma Merkezi
NOT_YET_RECRUITING
Yüreğir
United Kingdom
Velindre University NHS Trust
NOT_YET_RECRUITING
Cardiff
The Christie NHS Foundation Trust
NOT_YET_RECRUITING
Manchester
Nottingham University Hospitals NHS Trust
NOT_YET_RECRUITING
Nottingham
Contact Information
Primary
Taiho Oncology INC
medicalinformation@taihooncology.com
+1 844-878-2446
Time Frame
Start Date: 2025-11
Estimated Completion Date: 2032-10-01
Participants
Target number of participants: 360
Treatments
Experimental: Zipalertinib
Participants will receive adjuvant platinum-based chemotherapy consisting of cisplatin 75 milligrams per square meter (mg/m\^2) or carboplatin (area under concentration \[AUC\] 5 milligrams per milliliter per minute mg/mL/min) plus pemetrexed 500 mg/m\^2, administered via intravenous (IV) infusion, on 21-day cycle, in combination with zipalertinib 100 mg, orally, twice daily (BID).~After completion of chemotherapy, participants will continue on zipalertinib monotherapy 100 mg, orally, BID on 21-day cycle, until the participant meets any of the treatment discontinuation criteria.
Placebo_comparator: Placebo
Participants will receive adjuvant platinum-based chemotherapy consisting of cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/mL/min plus pemetrexed 500 mg/m\^2, administered via IV infusion, on 21-day cycle, in combination with zipalertinib matching-placebo 100 mg, orally, BID.~After completion of chemotherapy, participants will continue on zipalertinib matching-placebo monotherapy 100mg, orally, BID on 21-day cycle, until the participant meets any of the treatment discontinuation criteria.
Sponsors
Leads: Taiho Oncology, Inc.

This content was sourced from clinicaltrials.gov

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