A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

PHASE3RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

August 28, 2025

Primary Completion Date

October 31, 2029

Study Completion Date

October 31, 2032

Conditions
NSCLC, Stage IB-IIIALung CancerAdjuvantPost-surgicalEGFRExon 20Early Stage Lung CancerUncommon EGFR Mutations
Interventions
DRUG

Cisplatin

IV infusion.

DRUG

Carboplatin

IV infusion.

DRUG

Pemetrexed

IV infusion.

DRUG

TAS6417

Oral tablets.

DRUG

Zipalertinib Matching-placebo

Oral tablets.

Trial Locations (209)

2065

NOT_YET_RECRUITING

GenesisCare - North Shore, St Leonards

2200

NOT_YET_RECRUITING

Bankstown-Lidcombe Hospital, Bankstown

2650

NOT_YET_RECRUITING

Universitair Ziekenhuis Antwerpen, Edegem

3000

NOT_YET_RECRUITING

Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg, Leuven

3844

NOT_YET_RECRUITING

Ziekenhuis St Jansdal Harderwijk, Harderwijk

4763

NOT_YET_RECRUITING

Hanyang University Hospital, Seoul

6008

NOT_YET_RECRUITING

Saint John of God - Subiaco Hospital, Subiaco

6520

NOT_YET_RECRUITING

Memorial Ankara Hastanesi, Ankara

6680

NOT_YET_RECRUITING

Liv Hospital Ankara, Ankara

10016

NOT_YET_RECRUITING

Perlmutter Cancer Center - 34th Street, New York

10043

NOT_YET_RECRUITING

Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano

10060

NOT_YET_RECRUITING

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia, Candiolo

10065

NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center - New York, New York

10240

NOT_YET_RECRUITING

Chulabhorn Hospital, Bang Kapi

10300

NOT_YET_RECRUITING

Navamindradhiraj University - Faculty of Medicine Vajira Hospital, Bangkok

10400

NOT_YET_RECRUITING

Lampang Cancer Hospital, Muang

10408

NOT_YET_RECRUITING

National Cancer Center - Korea, Goyang-si

10450

NOT_YET_RECRUITING

Hospital Pulau Pinang, Pulau Pinang

10700

NOT_YET_RECRUITING

Faculty of Medicine Siriraj Hospital, Bangkoknoi

11527

NOT_YET_RECRUITING

General Hospital for Thoracic Diseases Sotiria, Athens

12200

NOT_YET_RECRUITING

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

13620

NOT_YET_RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

13823

NOT_YET_RECRUITING

Monza Oncology Day Hospital, Bucharest

14033

NOT_YET_RECRUITING

Hôpital Côte De Nacre, Caen

15036

NOT_YET_RECRUITING

IPOR - Instituto Peruano de Oncología & Radioterapia - Sede Principal, San Isidro

15038

NOT_YET_RECRUITING

Detecta Clínica, Surquillo

15082

NOT_YET_RECRUITING

Hospital Nacional Arzobispo Loayza, Lima Cercado

15121

NOT_YET_RECRUITING

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria, Alessandria

15586

NOT_YET_RECRUITING

Hospital Raja Perempuan Zainab II, Kota Bharu

16247

NOT_YET_RECRUITING

Catholic University of Korea St. Vincent's Hospital, Suwon

16499

NOT_YET_RECRUITING

Ajou University Hospital, Suwon

18016

NOT_YET_RECRUITING

Hospital Universitario Clínico San Cecilio PTS, Granada

18537

NOT_YET_RECRUITING

Metaxa Cancer Hospital of Piraeus, Athens

20007

NOT_YET_RECRUITING

Georgetown University School of Medicine, Washington D.C.

20025

NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale (ASST) di Bergamo Ovest, Legnano

20132

NOT_YET_RECRUITING

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele, Milan

20133

NOT_YET_RECRUITING

Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan

20141

NOT_YET_RECRUITING

Istituto Europeo di Oncologia, Milan

20162

NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

21280

NOT_YET_RECRUITING

Dicle Üniversitesi Tıp Fakültesi, Sur

22031

NOT_YET_RECRUITING

Virginia Cancer Specialists - Fairfax Office, Fairfax

22130

NOT_YET_RECRUITING

Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi, Edirne

22332

NOT_YET_RECRUITING

Inha University Hospital, Incheon

24125

NOT_YET_RECRUITING

Humanitas Gavazzeni, Bergamo

24127

NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII, Bergamo

27003

NOT_YET_RECRUITING

Hospital Universitario Lucus Augusti, Lugo

27100

NOT_YET_RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pavia

27310

NOT_YET_RECRUITING

Gaziantep Universitesi - Şahinbey Araştırma ve Uygulama Hastanesi, Şehitkamil

27584

NOT_YET_RECRUITING

Ozel Gaziantep Medical Point Hastanesi, Gaziantep

28033

NOT_YET_RECRUITING

MD Anderson Cancer Center Madrid, Madrid

28040

NOT_YET_RECRUITING

Hospital Universitario Fundación Jiménez Díaz, Madrid

28041

NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28204

NOT_YET_RECRUITING

Atrium Health Wake Forest Baptist - Comprehensive Cancer Center, Charlotte

28222

NOT_YET_RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda

28644

NOT_YET_RECRUITING

Chungbuk National University Hospital, Cheongju-si

29004

NOT_YET_RECRUITING

Hospital Quirónsalud Málaga, Málaga

30029

NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Nîmes, Nîmes

32763

NOT_YET_RECRUITING

Alpha Oncology Research, Orange City

33000

NOT_YET_RECRUITING

Hôpital Saint-André, Bordeaux

33063

NOT_YET_RECRUITING

D&H Cancer Research Center - Margate, Margate

34180

NOT_YET_RECRUITING

Memorial Bahçelievler Hospital, Bahçelievler

34295

NOT_YET_RECRUITING

İ.A.Ü. VM Medical Park Florya Hastanesi, Küçükçekmece

34517

NOT_YET_RECRUITING

İstinye Üniversite Hastanesi Liv Hospital Bahcesehir, Esenyurt

34722

NOT_YET_RECRUITING

T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul

35016

NOT_YET_RECRUITING

Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas de Gran Canaria

35033

NOT_YET_RECRUITING

Hôpital Pontchaillou, Rennes

35392

NOT_YET_RECRUITING

Universitätsklinikum Gießen und Marburg - Gießen, Giessen

35575

NOT_YET_RECRUITING

Izmir Ekonomi Universitesi Medical Point Hastanesi, Izmir

37019

NOT_YET_RECRUITING

Ospedale P. Pederzoli - Casa di Cura Privata S.p.A., Peschiera del Garda

37126

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona, Verona

37178

NOT_YET_RECRUITING

Preparaciones Oncológicas S.C., León

40138

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi, Bologna

41013

NOT_YET_RECRUITING

Hospital Universitario Virgen del Rocío, Seville

41124

NOT_YET_RECRUITING

Azienda Ospedaliero - Universitaria di Modena, Modena

41404

NOT_YET_RECRUITING

Kyungpook National University Chilgok Hospital, Daegu

42601

NOT_YET_RECRUITING

Keimyung University Dongsan Hospital, Daegu

43204

NOT_YET_RECRUITING

Hospital Universitari Sant Joan de Reus, Reus

44277

NOT_YET_RECRUITING

Hôpital Privé du Confluent, Nantes

44718

NOT_YET_RECRUITING

Gabrail Cancer and Research Center, Canton

44800

NOT_YET_RECRUITING

Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec, Saint-Herblain

45400

NOT_YET_RECRUITING

Medicana International Izmir Hastanesi, Turgutlu

46026

NOT_YET_RECRUITING

Hospital Universitari i Politècnic La Fe, Valencia

46300

NOT_YET_RECRUITING

Hospital Picaso, Petaling Jaya

47014

NOT_YET_RECRUITING

"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST", Meldola

47500

NOT_YET_RECRUITING

Sunway Medical Centre, Selangor Darul Ehsan

48022

NOT_YET_RECRUITING

Ospedale Santa Maria delle Croci di Ravenna, Lugo

48126

RECRUITING

Profound Research LLC at Michigan Hematology and Oncology Consultants, Dearborn

48202

NOT_YET_RECRUITING

Henry Ford Health System, Detroit

49055

NOT_YET_RECRUITING

Institut de Cancérologie de l'Ouest - Angers, Angers

49267

NOT_YET_RECRUITING

Kosin University Gospel Hospital, Pusan

50586

NOT_YET_RECRUITING

Hospital Kuala Lumpur, Kuala Lumpur

50612

NOT_YET_RECRUITING

Pusan National University Yangsan Hospital, Yangsan

51067

NOT_YET_RECRUITING

Kliniken der Stadt Köln, Cologne

52727

NOT_YET_RECRUITING

Gyeongsang National University Hospital, Jinju

53100

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte, Siena

54622

NOT_YET_RECRUITING

BioClinic Thessaloniki, Athens

55200

NOT_YET_RECRUITING

VM Medical Park Samsun Hastanesi, Atakum

57001

NOT_YET_RECRUITING

Interbalkan Medical Center of Thessaloniki, Thessaloniki

57124

NOT_YET_RECRUITING

Azienda Unità Sanitaria Locale Toscana Nord Ovest, Livorno

58128

NOT_YET_RECRUITING

Chonnam National University Hwasun Hospital, Hwasun-gun

60126

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Delle Marche, Ancona

60488

NOT_YET_RECRUITING

Krankenhaus Nordwest, Frankfurt am Main

60612

NOT_YET_RECRUITING

University of Illinois Medical Center, Chicago

68100

NOT_YET_RECRUITING

Hôpital Emile Muller, Mulhouse

69008

NOT_YET_RECRUITING

Centre Léon Bérard, Lyon

69495

NOT_YET_RECRUITING

Centre Hospitalier Lyon-Sud, Pierre-Bénite

72037

NOT_YET_RECRUITING

Centre Hospitalier Le Mans, Le Mans

72530

NOT_YET_RECRUITING

Clínica Integral Internacional de Oncología S de RL de CV, Mirador

74245

NOT_YET_RECRUITING

SLK-Kliniken - Fachklinik Löwenstein, Löwenstein

75014

NOT_YET_RECRUITING

Groupe Hospitalier Paris Saint-Joseph, Paris

75018

NOT_YET_RECRUITING

Hôpital Bichat - Claude-Bernard, Paris

80147

NOT_YET_RECRUITING

Ospedale del Mare, Napoli

90110

NOT_YET_RECRUITING

Songklanagarind Hospital, Hat Yai

91010

NOT_YET_RECRUITING

City of Hope Comprehensive Cancer Center - Duarte, Duarte

92100

NOT_YET_RECRUITING

Hôpital Ambroise-Paré, Boulogne-Billancourt

94000

NOT_YET_RECRUITING

Centre Hospitalier Intercommunal de Créteil, Créteil

94805

NOT_YET_RECRUITING

Gustave Roussy, Villejuif

95125

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico, Catania

99508

NOT_YET_RECRUITING

Alaska Oncology and Hematology, Anchorage

100010

NOT_YET_RECRUITING

Clinica MC Gral Ploiesti, Ploieşti

168583

NOT_YET_RECRUITING

National Cancer Centre Singapore, Singapore

300166

NOT_YET_RECRUITING

Oncocenter - Oncologie Clinica, Timișoara

308433

NOT_YET_RECRUITING

Tan Tock Seng Hospital, Singapore

407280

NOT_YET_RECRUITING

Centrul de Radioterapie Amethyst Cluj, Floreşti

440192

NOT_YET_RECRUITING

Spitalul Județean de Urgență Satu Mare, Satu Mare

905900

NOT_YET_RECRUITING

Ovidius Clinical Hospital, Ovidiu

C1122

NOT_YET_RECRUITING

Instituto Argentino de Diagnóstico y Tratamiento, Ciudad Autónoma de Buenos Aires

B2700KMP

NOT_YET_RECRUITING

Centro de Investigación Pergamino SA, Pergamino

B1629AHJ

NOT_YET_RECRUITING

Hospital Universitario Austral, Pilar

X5008HHW

NOT_YET_RECRUITING

CEMAIC - Centro de Especialidades Médicas Ambulatorias e Investigación Clínica, Córdoba

60115-281

NOT_YET_RECRUITING

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

60335-480

NOT_YET_RECRUITING

Centro Regional Integrado de Oncologia, Fortaleza

29308-065

NOT_YET_RECRUITING

Centro de Pesquisas Clínicas Em Oncologia - CPCO, Cachoeiro de Itapemirim

29043-260

NOT_YET_RECRUITING

Hospital Santa Rita, Vitória

40170-110

NOT_YET_RECRUITING

Núcleo de Oncologia da Bahia Ondina - NOB, Salvador

70390-150

NOT_YET_RECRUITING

Oncoclinicas Oncovida - Brasilia, Brasília

30110-022

NOT_YET_RECRUITING

Cetus Oncologia - Unidade Belo Horizonte, Belo Horizonte

30130-090

NOT_YET_RECRUITING

Cenantron Centro Avançado de Tratamento Oncológico, Belo Horizonte

80810-050

NOT_YET_RECRUITING

Centro Integrado de Oncologia de Curitiba (CIONC), Curitiba

50070-902

NOT_YET_RECRUITING

Instituto de Medicina Integral Professor Fernando Figueira, Recife

64.049-200

NOT_YET_RECRUITING

Centro de Pesquisa Vencer e Oncoclínica - Teresina, Teresina

22281-100

NOT_YET_RECRUITING

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

59062-000

NOT_YET_RECRUITING

Liga Contra o Câncer - Centro Avançado de Oncologia, Natal

97015-450

NOT_YET_RECRUITING

Clínica Viver, Centro Santa Maria

95900-022

NOT_YET_RECRUITING

Hospital Bruno Born, Lajeado

99010-090

NOT_YET_RECRUITING

Hospital São Vicente de Paulo, Passo Fundo

90050-170

NOT_YET_RECRUITING

Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre, Porto Alegre

90440-010

NOT_YET_RECRUITING

Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre, Porto Alegre

91210-250

NOT_YET_RECRUITING

Hospital Mãe de Deus - Centro Integrado de Oncologia, Porto Alegre

88020-210

NOT_YET_RECRUITING

Grupo ELORA, Florianópolis

89201-260

NOT_YET_RECRUITING

CHO Centro - Centro de Hematologia e Oncologia de Joinville, Joinville

14784-400

NOT_YET_RECRUITING

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

17210-180

NOT_YET_RECRUITING

Hospital Amaral Carvalho, Jaú

18030-005

NOT_YET_RECRUITING

Instituto de Oncologia de Sorocaba, Sorocaba

01323-001

NOT_YET_RECRUITING

A Beneficência Portuguesa de São Paulo, São Paulo

04039-004

NOT_YET_RECRUITING

Instituto de Assistência Médica ao Servidor Público Estadual, São Paulo

N6A 4G5

NOT_YET_RECRUITING

London Health Sciences Centre, London

H3G 1Y6

NOT_YET_RECRUITING

William Osler Health System - Brampton Civic Hospital, Montreal

49 933

NOT_YET_RECRUITING

Centre Hospitalier Universitaire d'Angers, Angers

115 22

NOT_YET_RECRUITING

Saint Savvas Anticancer - Oncological Hospital of Athens, Athens

Unknown

NOT_YET_RECRUITING

Humanity & Health Clinical Trial Centre, Hong Kong

NOT_YET_RECRUITING

Queen Mary Hospital - Hong Kong, Hong Kong

NOT_YET_RECRUITING

Princess Margaret Hospital, Kowloon

00184

NOT_YET_RECRUITING

Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata, Roma

464-8681

NOT_YET_RECRUITING

Aichi Cancer Center, Nagoya

830-0011

NOT_YET_RECRUITING

Kurume University Hospital, Kurume-Shi

734-8551

NOT_YET_RECRUITING

Hiroshima University Hospital, Hiroshima

811-1395

NOT_YET_RECRUITING

National Hospital Organization Kyushu Cancer Center, Fukuoka

673-8558

NOT_YET_RECRUITING

Hyogo Cancer Center, Akashi

650-0017

NOT_YET_RECRUITING

Kobe University Hospital, Kobe

241-8515

NOT_YET_RECRUITING

Kanagawa Cancer Center, Yokohama

980-8574

NOT_YET_RECRUITING

Tohoku University Hospital, Sendai

852-8501

NOT_YET_RECRUITING

Nagasaki University Hospital, Nagasaki

573-1191

NOT_YET_RECRUITING

Kansai Medical University Hospital, Hirakata

589-8511

NOT_YET_RECRUITING

Kindai University Hospital, Osakasayama-Shi

411-8777

NOT_YET_RECRUITING

Shizuoka Cancer Center, Sunto-gun

277-8577

NOT_YET_RECRUITING

National Cancer Center Hospital East, Kashiwa-shi

135-8550

NOT_YET_RECRUITING

Cancer Institute Hospital of JFCR, Koto

700-8558

NOT_YET_RECRUITING

Okayama University Hospital, Okayama

534-0021

RECRUITING

Osaka City General Hospital, Osaka

541-8567

NOT_YET_RECRUITING

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute, Osaka

06760

NOT_YET_RECRUITING

Centro Oncológico Alianza XXI, Mexico City

6525 GA

NOT_YET_RECRUITING

Radboud Universitair Medisch Centrum, Nijmegen

2333 ZA

NOT_YET_RECRUITING

Leids Universitair Medisch Centrum (LUMC), Leiden

62-500

NOT_YET_RECRUITING

Przychodnia Lekarska KOMED Roman Karaszewski, Konin

50-981

NOT_YET_RECRUITING

4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ, Wroclaw

35-021

NOT_YET_RECRUITING

Mruk-Med I Sp. z o.o., Rzeszów

10-357

NOT_YET_RECRUITING

Warmińsko-mazurskie Centrum Chorób Płuc w Olsztynie, Olsztyn

21-500

NOT_YET_RECRUITING

Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej, Biała Podlaska

022328

NOT_YET_RECRUITING

Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu, Bucharest

561-712

NOT_YET_RECRUITING

Jeonbuk National University Hospital, Jeonju

02841

NOT_YET_RECRUITING

Korea University Anam Hospital, Seoul

03722

NOT_YET_RECRUITING

Severance Hospital, Seoul

05030

NOT_YET_RECRUITING

Konkuk University Medical Center, Seoul

06591

NOT_YET_RECRUITING

The Catholic University of Korea - Seoul St. Mary's Hospital, Seoul

08308

NOT_YET_RECRUITING

Korea University Guro Hospital, Seoul

03080

NOT_YET_RECRUITING

Seoul National University Hospital, Seoul

07061

NOT_YET_RECRUITING

Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul

07120

NOT_YET_RECRUITING

Hospital Universitario Son Espases, Palma de Mallorca

08916

NOT_YET_RECRUITING

Institut Català d'Oncologia Badalona, Badalona

08028

NOT_YET_RECRUITING

Instituto Oncológico Dr Rosell, Barcelona

08035

NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebrón, Barcelona

01250

NOT_YET_RECRUITING

Başkent Üniversitesi Adana Dr Turgut Noyan Uygulama ve Araştirma Merkezi, Yüreğir

06010

NOT_YET_RECRUITING

Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi, Etlik

01040

NOT_YET_RECRUITING

Medical Park Seyhan Hastanesi, Adana

01370

NOT_YET_RECRUITING

T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi, Adana

M20 4BX

NOT_YET_RECRUITING

The Christie NHS Foundation Trust, Manchester

NG5 1PB

NOT_YET_RECRUITING

Nottingham University Hospitals NHS Trust, Nottingham

CF14 2TL

NOT_YET_RECRUITING

Velindre University NHS Trust, Cardiff

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY

NCT07128199 - A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection | Biotech Hunter | Biotech Hunter