Lung CancerPhase 3REZILIENT4NCT07128199
A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection
A Phase 3 study testing TAS6417 in people with Lung Cancer and Adjuvant, run by Taiho Oncology, Inc. at 253 sites in 24 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Adjuvant, Post-surgical
- What is being tested?
- TAS6417
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 253 sitesin 24 countries
- Study dates
- 22 Dec 2025to 1 Oct 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) exons 18-21 of the EGFR tyrosine kinase domain
- Baseline imaging assessment of the brain (MRI [preferred modality] or CT scan) performed within 8 weeks prior to randomization must show no evidence of brain metastasis
- Complete surgical resection of the primary NSCLC is mandatory with negative surgical margins and systematic lymph node sampling or dissection.
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- Complete recovery from surgery, including post-operative wound healing, and prior adjuvant chemotherapy (if applicable) at the time of randomization. Randomization timing is defined as follows:
- For participants without prior adjuvant chemotherapy: 4 weeks and 12 weeks following surgery.
- For participants with prior adjuvant chemotherapy: 4 weeks and 8 weeks after the last dose of adjuvant chemotherapy.
- Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1.
- Pathologic (post-operative) Stage IB, IIA, IIB, or IIIA according to the AJCC 9th tumor nodes metastasis (TNM) staging system for lung cancer. In addition, participants with stage IIIB are eligible when regional lymph node involvement is N2.
- Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers.
Who cannot join
- Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research.
- Treatment with any of the following within the time frame specified:
- Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time.
- Pre-operative or post-operative or planned radiation therapy for the current lung cancer.
- Any prior systemic anticancer therapy for NSCLC, including preoperative (neoadjuvant) chemotherapy, immunotherapy, or investigational therapy. (Exception: Participants who have received postoperative adjuvant platinum-based chemotherapy up to 4 cycles are permitted)
- Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study treatment.
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- Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known.
- Has received only wedge resections (complete anatomic segmentectomy is acceptable).
- Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis or any evidence of clinically active ILD/pneumonitis.
- Unable to swallow tablets or has any disease or condition that may significantly affect gastrointestinal (GI) absorption of zipalertinib (such as inflammatory bowel disease, malabsorption syndrome, or prior significant bowel resection).
- Has a history of any other cancer except for any of the following:
- Non-melanoma skin cancer treated with curative intent
- Carcinoma in situ treated with curative intent
- Other curatively treated cancer, with no evidence of disease for >3 years following the end of treatment and, in the opinion of the treating physician, has no substantial risk of recurrence.
- Concurrent malignancy of which natural history does not have the potential to interfere with the safety or efficacy assessment (eg, Gleason 6 prostate cancer)
- Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment.
- Active bleeding disorders.
- Known hypersensitivity to the ingredients in zipalertinib/placebo or any drugs similar in structure or class.
Trial locations and contacts
253 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
253 sites in 24 countries
United States30 sites, 30 recruiting
- Recruiting
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
- Not yet recruiting
Virginia Cancer Specialists - Arlington Office
Arlington, Virginia, 22201
- Not yet recruiting
Memorial Sloan Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, 07920
- Recruiting
Gabrail Cancer and Research Center
Canton, Ohio, 44718
- Not yet recruiting
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
Charlotte, North Carolina, 28204
- Recruiting
University of Illinois Medical Center
Chicago, Illinois, 60612
- Not yet recruiting
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, 11725
- Recruiting
Profound Research LLC at Michigan Hematology and Oncology Consultants
Dearborn, Michigan, 48126
- Not yet recruiting
Henry Ford Health System
Detroit, Michigan, 48202
- Not yet recruiting
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, 91010
- Not yet recruiting
Durham Veterans Affairs Health Care System
Durham, North Carolina, 27705
- Not yet recruiting
Memorial Sloan Kettering Cancer Center - Westchester
East White Plains, New York, 10604
- Recruiting
Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, 22031
- Not yet recruiting
City of Hope Comprehensive Cancer Center Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
- Not yet recruiting
Scripps Clinic Torrey Pines
La Jolla, California, 92037
- Not yet recruiting
Long Island Jewish Medical Center
Lake Success, New York, 11042
- Not yet recruiting
Virginia Cancer Specialists - Bristow Office
Manassas, Virginia, 20110
- Recruiting
D&H Cancer Research Center - Margate
Margate, Florida, 33063
- Not yet recruiting
Memorial Sloan Kettering Cancer Center - Monmouth
Middletown, New Jersey, 07748
- Not yet recruiting
Memorial Sloan Kettering Cancer Center - Bergen
Montvale, New Jersey, 07645
- Not yet recruiting
Perlmutter Cancer Center - 34th Street
New York, New York, 10016
- Recruiting
Memorial Sloan Kettering Cancer Center - New York
New York, New York, 10065
- Not yet recruiting
City of Hope - Atlanta
Newnan, Georgia, 30265
- Recruiting
Alpha Oncology Research
Orange City, Florida, 32763
- Not yet recruiting
Virginia Cancer Specialists - Reston
Reston, Virginia, 20190
- Not yet recruiting
Gibbs Cancer Center and Research Institute Spartanburg
Spartanburg, South Carolina, 29303
- Not yet recruiting
Memorial Sloan Kettering Cancer Center - Nassau
Uniondale, New York, 11553
- Not yet recruiting
Kaiser Permanente - Vallejo Medical Center
Vallejo, California, 94589
- Recruiting
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20007
- Not yet recruiting
Virginia Cancer Specialists - Woodbridge Office
Woodbridge, Virginia, 22191
Brazil26 sites, 26 recruiting
- Not yet recruiting
Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor
Barretos, São Paulo, 14784-400
- Not yet recruiting
Cetus Oncologia - Unidade Belo Horizonte
Belo Horizonte, Minas Gerais, 30110-022
- Not yet recruiting
Cenantron Centro Avançado de Tratamento Oncológico
Belo Horizonte, Minas Gerais, 30130-090
- Not yet recruiting
Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro
Botafogo, Rio de Janeiro, 22281-100
- Not yet recruiting
Oncoclinicas Oncovida - Brasilia
Brasília, Federal District, 70390-150
- Not yet recruiting
Centro de Pesquisas Clínicas Em Oncologia - CPCO
Cachoeiro de Itapemirim, Espírito Santo, 29308-065
- Not yet recruiting
Clínica Viver
Centro Santa Maria, Rio Grande do Sul, 97015-450
- Not yet recruiting
Centro Integrado de Oncologia de Curitiba (CIONC)
Curitiba, Paraná, 80810-050
- Not yet recruiting
Grupo ELORA
Florianópolis, Santa Catarina, 88020-210
- Not yet recruiting
NOHC - Núcleo de Oncologia e Hematologia do Ceará - José Lourenço
Fortaleza, Ceará, 60115-281
- Not yet recruiting
Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60335-480
- Not yet recruiting
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-180
- Not yet recruiting
CHO Centro - Centro de Hematologia e Oncologia de Joinville
Joinville, Santa Catarina, 89201-260
- Not yet recruiting
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900-022
- Not yet recruiting
Liga Contra o Câncer - Centro Avançado de Oncologia
Natal, Rio Grande do Norte, 59062-000
- Not yet recruiting
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-090
- Not yet recruiting
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
- Not yet recruiting
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
Porto Alegre, Rio Grande do Sul, 90440-010
- Not yet recruiting
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre, Rio Grande do Sul, 91210-250
- Not yet recruiting
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-902
- Not yet recruiting
Núcleo de Oncologia da Bahia Ondina - NOB
Salvador, Estado de Bahia, 40170-110
- Not yet recruiting
A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, 01323-001
- Not yet recruiting
Instituto de Assistência Médica ao Servidor Público Estadual
São Paulo, São Paulo, 04039-004
- Not yet recruiting
Instituto de Oncologia de Sorocaba
Sorocaba, São Paulo, 18030-005
- Not yet recruiting
Centro de Pesquisa Vencer e Oncoclínica - Teresina
Teresina, Piauí, 64.049-200
- Not yet recruiting
Hospital Santa Rita
Vitória, Espírito Santo, 29043-260
Italy26 sites, 26 recruiting
- Recruiting
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria
Alessandria, Alessandria, 15121
- Recruiting
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Ancona, 60126
- Not yet recruiting
Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
Bergamo, Bergamo, 24127
- Not yet recruiting
Humanitas Gavazzeni
Bergamo, 24125
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna, Bologna, 40138
- Recruiting
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060
- Not yet recruiting
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico
Catania, Catania, 95125
- Not yet recruiting
Azienda Socio Sanitaria Territoriale (ASST) di Bergamo Ovest
Legnano, Milan, 20025
- Recruiting
Azienda Unita Sanitaria Locale toscana Nord Ovest
Livorno, Livorno, 57124
- Not yet recruiting
Azienda Unità Sanitaria Locale Toscana Nord Ovest
Livorno, Livorno, 57124
- Not yet recruiting
Ospedale Santa Maria delle Croci di Ravenna
Lugo, Ravenna, 48022
- Not yet recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forlì-Cesena, 47014
- Not yet recruiting
Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata
Milan, Milan, 20132
- Not yet recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Milan, 20132
- Not yet recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Milan, 20133
- Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Milan, 20141
- Not yet recruiting
Istituto Europeo di Oncologia
Milan, Milan, 20141
- Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Milan, 20162
- Not yet recruiting
Azienda Ospedaliero - Universitaria di Modena
Modena, Modena, 41124
- Recruiting
Ospedale del Mare
Naples, Naples, 80147
- Not yet recruiting
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Torino, 10043
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
- Not yet recruiting
Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019
- Not yet recruiting
Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata
Roma, Rome, 00184
- Not yet recruiting
Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
Siena, Siena, 53100
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Verona, 37126
France25 sites, 25 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire d'Angers
Angers, Maine-et-Loire, 49 933
- Recruiting
CHU d Angers
Angers, Maine-et-Loire, 49 933
- Recruiting
Institut de Cancérologie de l'Ouest - Angers
Angers, Maine-et-Loire, 49055
- Recruiting
Hôpital Saint-André
Bordeaux, Aquitane, 33000
- Recruiting
Hôpital Ambroise-Paré
Boulogne-Billancourt, Île-de-France Region, 92100
- Recruiting
Hôpital Louis Pradel
Bron, Auvergne-Rhône-Alpes, 69500
- Recruiting
Hôpital Côte De Nacre
Caen, Basse-Normandie, 14033
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, Île-de-France Region, 94000
- Recruiting
Hopital Nord Ouest
Gleizé, Rhône, 69 655
- Recruiting
Centre Hospitalier Le Mans
Le Mans, Pays de la Loire Region, 72037
- Recruiting
Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes, 69004
- Recruiting
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, 69008
- Recruiting
Hôpital Emile Muller
Mulhouse, Grand Est, 8051
- Recruiting
Hopital Prive du Confluet
Nantes, Pays de la Loire Region, 44277
- Not yet recruiting
Hôpital Privé du Confluent
Nantes, Pays de la Loire Region, 44277
- Not yet recruiting
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029
- Recruiting
CHU de Nimes - Caremeau Nord
Nîmes, Occitanie, 30029
- Recruiting
Hôpital Universitaire Pitié Salpêtrière
Paris, Paris, 75013
- Recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
- Recruiting
Hôpital Bichat - Claude-Bernard
Paris, Île-de-France Region, 75018
- Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495
- Recruiting
Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35033
- Recruiting
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
Saint-Herblain, Loire-Atlantique, 44800
- Not yet recruiting
L'Hôpital Nord-Ouest (HNO) - Villefranche-sur-Saône
Villefranche-de-Rouergue, Aveyron, 12200
- Not yet recruiting
Gustave Roussy
Villejuif, Val-De-Marne, 94800
Japan23 sites, 23 recruiting
- Recruiting
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, Hukuoka [Fukuoka], 811-1395
- Not yet recruiting
Saitama Medical University - International Medical Center
Hidaka-Shi, Saltama, 350-1298
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
- Recruiting
Hiroshima University Hospital
Hiroshima, Hirosima [Hiroshima], 734-8551
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Tiba [Chiba], 277-8577
- Recruiting
Kobe University Hospital
Kobe, Hyōgo, 650-0017
- Recruiting
Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550
- Not yet recruiting
Kurume University Hospital
Kurume-Shi, Fukuoka, 830-0011
- Recruiting
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
- Not yet recruiting
Nagoya Univeristy Hospital
Nagoya, Aichi-ken, 466-8560
- Recruiting
Aichi Cancer Center
Nagoya, Aiti [Aichi], 464-8681
- Recruiting
Okayama University Hospital
Okayama, 700-8558
- Recruiting
Osaka City General Hospital
Osaka, Osaka, 534-0021
- Recruiting
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka, Osaka, 541-8567
- Recruiting
Kindai University Hospital
Osakasayama-Shi, Osaka, 589-8511
- Recruiting
Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
- Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
- Recruiting
Shizuoka Cancer Center
Sunto-gun, Sizuoka [Shizuoka], 411-8777
- Not yet recruiting
National Cancer Center Hospital
Tokyo, Tokyo, 104-0045
- Recruiting
Yamagata University Hospital
Yamagata, Yamagata, 990-9585
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
South Korea21 sites, 21 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, Gyeonggido [Kyonggi-do], 28644
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu, Daegu Gwang'Yeogsi [Taegu-Kwangyokshi], 41404
- Recruiting
Keimyung University Dongsan Hospital
Daegu, Gyeongsangbugdo [Kyongsangbuk-do], 42601
- Recruiting
National Cancer Center - Korea
Goyang-si, Gyeonggido [Kyonggi-do], 10408
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 58128
- Recruiting
Inha University Hospital
Incheon, Incheon Gwang'Yeogsi [Inch'On-Kwangyokshi], 22332
- Recruiting
Jeonbuk National University Hospital
Jeonju, Jeonrabugdo [Chollabuk-do], 561-712
- Recruiting
Gyeongsang National University Hospital
Jinju, Gyeongsangnamdo [Kyongsangnam-do], 52727
- Recruiting
Kosin University Gospel Hospital
Pusan, Gyeongsangnam-do, 49267
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Seoul, 07061
- Recruiting
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 02841
- Recruiting
Severance Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 03722
- Recruiting
Konkuk University Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 05030
- Recruiting
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 06591
- Recruiting
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 08308
- Not yet recruiting
Hanyang University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 4763
- Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Spain17 sites, 17 recruiting
- Recruiting
Institut Català d'Oncologia Badalona
Badalona, Barcelona, 08916
- Not yet recruiting
Instituto Oncológico Dr Rosell
Barcelona, Barcelona, 08028
- Recruiting
Hospital Universitari Vall d'Hebrón
Barcelona, Barcelona, 08035
- Not yet recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
- Recruiting
Hospital Universitario Clínico San Cecilio PTS
Granada, Granada, 18016
- Not yet recruiting
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Las Palmas, 35016
- Not yet recruiting
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
- Recruiting
MD Anderson Cancer Center Madrid
Madrid, Madrid, 28033
- Not yet recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
- Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28222
- Not yet recruiting
Hospital Quirónsalud Málaga
Málaga, Málaga, 29004
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
- Recruiting
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204
- Not yet recruiting
Hospital de Sabadell
Sabadell, Barcelona, 08208
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia, València, 46026
Turkey (Türkiye)17 sites, 17 recruiting
- Not yet recruiting
Medical Park Seyhan Hastanesi
Adana, Adana, 01040
- Not yet recruiting
T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi
Adana, Adana, 01370
- Not yet recruiting
Memorial Ankara Hastanesi
Ankara, Ankara, 6520
- Not yet recruiting
Liv Hospital Ankara
Ankara, Ankara, 6680
- Not yet recruiting
VM Medical Park Samsun Hastanesi
Atakum, Samsun, 55200
- Not yet recruiting
Memorial Bahçelievler Hospital
Bahçelievler, Istanbul, 34180
- Not yet recruiting
Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
Edirne, Edirne, 22130
- Not yet recruiting
İstinye Üniversite Hastanesi Liv Hospital Bahcesehir
Esenyurt, Istanbul, 34517
- Not yet recruiting
Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi
Etlik, Ankara, 06010
- Not yet recruiting
Ozel Gaziantep Medical Point Hastanesi
Gaziantep, Gaziantep, 27584
- Not yet recruiting
T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, Istanbul, 34722
- Not yet recruiting
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, İzmir, 35575
- Not yet recruiting
İ.A.Ü. VM Medical Park Florya Hastanesi
Küçükçekmece, Istanbul, 34295
- Not yet recruiting
Gaziantep Universitesi - Şahinbey Araştırma ve Uygulama Hastanesi
Şehitkamil, Gaziantep, 27310
- Not yet recruiting
Dicle Üniversitesi Tıp Fakültesi
Sur, Diyarbakır, 21280
- Not yet recruiting
Medicana International Izmir Hastanesi
Turgutlu, Manisa, 45400
- Not yet recruiting
Başkent Üniversitesi Adana Dr Turgut Noyan Uygulama ve Araştirma Merkezi
Yüreğir, Adana, 01250
Romania7 sites, 7 recruiting
- Recruiting
Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu
Bucharest, Bucharest, 022328
- Not yet recruiting
Monza Oncology Day Hospital
Bucharest, Bucharest, 13823
- Not yet recruiting
Centrul de Radioterapie Amethyst Cluj
Floreşti, Cluj, 407280
- Recruiting
Ovidius Clinical Hospital
Ovidiu, Constanța County, 905900
- Not yet recruiting
Clinica MC Gral Ploiesti
Ploieşti, Prahova, 100010
- Not yet recruiting
Spitalul Județean de Urgență Satu Mare
Satu Mare, Satu Mare County, 440192
- Recruiting
Oncocenter - Oncologie Clinica
Timișoara, Timiș County, 300166
Thailand6 sites, 6 recruiting
- Not yet recruiting
Chulabhorn Hospital
Bang Kapi, Bangkok, 10240
- Not yet recruiting
Navamindradhiraj University - Faculty of Medicine Vajira Hospital
Bangkok, Khet Dusit, 10300
- Not yet recruiting
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
- Not yet recruiting
Songklanagarind Hospital
Hat Yai, Changwat Songkhla, 90110
- Not yet recruiting
Lampang Cancer Hospital
Muang, Changwat Lampang, 10400
- Not yet recruiting
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330
Canada5 sites, 5 recruiting
- Not yet recruiting
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, L6R317
- Not yet recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
- Not yet recruiting
London Health Sciences Centre
London, Ontario, N6A 4G5
- Not yet recruiting
Sunnybrook Health Sciences Centre - Bayview Campus
Toronto, Ontario, M4N3M5
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9
Greece5 sites, 5 recruiting
- Not yet recruiting
Saint Savvas Anticancer - Oncological Hospital of Athens
Athens, Attica, 115 22
- Not yet recruiting
General Hospital for Thoracic Diseases Sotiria
Athens, Attica, 11527
- Not yet recruiting
Metaxa Cancer Hospital of Piraeus
Athens, Attica, 18537
- Not yet recruiting
BioClinic Thessaloniki
Athens, Central Macedonia, 54622
- Not yet recruiting
Interbalkan Medical Center of Thessaloniki
Thessaloniki, Central Macedonia, 57001
Malaysia5 sites, 5 recruiting
- Not yet recruiting
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
- Not yet recruiting
Hospital Picaso
Petaling Jaya, Selangor, 46300
- Recruiting
Hospital Pulau Pinang
Pulau Pinang, Pulau Pinang, 10450
- Recruiting
Sunway Medical Centre
Selangor Darul Ehsan, 47500
Peru5 sites, 5 recruiting
- Not yet recruiting
Hospital Nacional Arzobispo Loayza
Lima Cercado, Lima region, 15082
- Not yet recruiting
Clínicas Oncosalud Sede Guardia Civil
San Borja, Lima region, 15036
- Not yet recruiting
Luis Alberto Vera Valdivia
San Borja, Lima region, 15036
- Not yet recruiting
IPOR - Instituto Peruano de Oncología & Radioterapia - Sede Principal
San Isidro, Lima region, 15036
- Not yet recruiting
Detecta Clínica
Surquillo, Lima region, 15038
Argentina4 sites, 4 recruiting
- Not yet recruiting
Instituto Argentino de Diagnóstico y Tratamiento
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1122
- Not yet recruiting
CEMAIC - Centro de Especialidades Médicas Ambulatorias e Investigación Clínica
Córdoba, Córdoba Province, X5008HHW
- Not yet recruiting
Centro de Investigación Pergamino SA
Pergamino, Buenos Aires, B2700KMP
- Not yet recruiting
Hospital Universitario Austral
Pilar, Buenos Aires, B1629AHJ
Germany4 sites, 3 recruiting
- Recruiting
Kliniken der Stadt Köln
Cologne, North Rhine-Westphalia, 51067
- Not yet recruiting
Krankenhaus Nordwest
Frankfurt am Main, Hesse, 60488
- Not yet recruiting
Universitätsklinikum Gießen und Marburg - Gießen
Giessen, Hesse, 35392
- Withdrawn
SLK-Kliniken - Fachklinik Löwenstein
Löwenstein, Baden-Wurttemberg, 74245
Hong Kong4 sites, 4 recruiting
- Not yet recruiting
Hong Kong Sanatorium and Hospital
Happy Valley
- Recruiting
Humanity & Health Clinical Trial Centre
Hong Kong
- Recruiting
Queen Mary Hospital - Hong Kong
Hong Kong
- Not yet recruiting
Princess Margaret Hospital
Kowloon
Singapore4 sites, 4 recruiting
- Not yet recruiting
Curie Oncology - Farrer - 10-05
Singapore, Central Singapore, 217562
- Recruiting
P.H Feng Research Centre
Singapore, Central Singapore, 308433
- Recruiting
Tan Tock Seng Hospital
Singapore, North East, 308433
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Velindre University NHS Trust
Cardiff, Wales, CF14 2TL
- Recruiting
The Christie NHS Foundation Trust
Manchester, England, M20 4BX
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, England, NG5 1PB
- Not yet recruiting
Torbay and South Devon NHS Foundation Trust
Torquay, England, TQ27AA
Australia3 sites, 3 recruiting
- Not yet recruiting
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200
- Recruiting
GenesisCare - North Shore
St Leonards, New South Wales, 2065
- Recruiting
Saint John of God - Subiaco Hospital
Subiaco, Western Australia, 6008
Belgium3 sites, 3 recruiting
- Not yet recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, 2650
- Not yet recruiting
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, 3000
- Not yet recruiting
Algemeen Ziekenhuis Sint-Maarten
Mechelen, Antwerpen, 2800
Mexico3 sites, 3 recruiting
- Not yet recruiting
Preparaciones Oncológicas S.C.
León, Guanajuato, 37178
- Not yet recruiting
Centro Oncológico Alianza XXI
Mexico City, Mexico City, 06760
- Not yet recruiting
Clínica Integral Internacional de Oncología S de RL de CV
Mirador, Puebla, 72530
Netherlands3 sites, 3 recruiting
- Recruiting
Ziekenhuis St Jansdal Harderwijk
Harderwijk, Gelderland, 3844
- Recruiting
Leids Universitair Medisch Centrum (LUMC)
Leiden, South Holland, 2333 ZA
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6525 GA
Poland3 sites, 2 recruiting
- Recruiting
Warmińsko-mazurskie Centrum Chorób Płuc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-357
- Recruiting
Mruk-Med I Sp. z o.o.
Rzeszów, Podkarpackie Voivodeship, 35-021
- Withdrawn
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, Lower Silesian Voivodeship, 50-981
About this study
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)
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).
Read the detailed description
This study will evaluate zipalertinib, a novel EGFR tyrosine kinase inhibitor (TKI) versus placebo in participants with resected early stage NSCLC harboring uncommon EGFRmt.
Approximately 360 participants will be randomized to:
Arm A: Zipalertinib twice daily (BID) monotherapy OR
Arm B: Placebo BID monotherapy.
An independent data monitoring committee (IDMC) will be established to monitor interim safety data.
- Conditions
- Lung Cancer, Adjuvant, Post-surgical, EGFR, Exon 20, Early Stage Lung Cancer
- Being tested
- TAS6417, Zipalertinib Matching-placebo
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS6417Drug
Also called Zipalertinib, CLN-081
Oral tablets.
Zipalertinib Matching-placeboDrug
Oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Zipalertinib | Experimental | Participants will receive zipalertinib orally until the participant meets any of the treatment discontinuation criteria. Receives: Drug: TAS6417 |
| Placebo | Placebo comparator | Participants will receive zipalertinib matching-placebo, until the participant meets any of the treatment discontinuation criteria. Receives: Drug: Zipalertinib Matching-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS) as Assessed by the Investigator
Measured: Up to 5 years
Secondary outcomes (11)
Disease-free Survival Rate
Measured: Up to 5 years
Overall Survival (OS)
Measured: Up to 5 years
Overall Survival Rate
Measured: Up to 5 years
DFS of Central Nervous System (cDFS)
Measured: Up to 5 years
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Measured: Up to 5 years
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Measured: Up to 5 years
Number of Participants with Clinically Significant Changes in Vital Signs
Measured: Up to 5 years
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Measured: Up to 5 years
Number of Participants With Change in Left Ventricular Ejection Fraction (LVEF) Evaluated Using Electrocardiography (ECHO) and Multigated Acquisition (MUGA) Scan
Measured: Up to 5 years
Change in EuroQuality of Life-5 Dimensional 3-Level (EQ-5D-3L)
EQ-5D-3L is a standardized measure of the participant's health-related quality of life (QoL). EQ-5D is a 5-item questionnaire that assesses 5 domains.
Measured: Baseline, up to 5 years
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scores
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start22 Dec 2025
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128199
- Sponsor's protocol ID
- TAS6417-302
- Other IDs
- 2025-521775-31-00, 2025
- Acronym
- REZILIENT4
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07128199
- Acronym / sponsor ID
- REZILIENT4 / TAS6417-302
- Conditions
- Lung Cancer, Adjuvant, Post-surgical, EGFR, Exon 20, Early Stage Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study will evaluate zipalertinib, a novel EGFR tyrosine kinase inhibitor (TKI) versus placebo in participants with resected early stage NSCLC harboring uncommon EGFRmt.
Approximately 360 participants will be randomized to:
Arm A: Zipalertinib twice daily (BID) monotherapy OR
Arm B: Placebo BID monotherapy.
An independent data monitoring committee (IDMC) will be established to monitor interim safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zipalertinib | Experimental | Drug: TAS6417Participants will receive zipalertinib orally until the participant meets any of the treatment discontinuation criteria. |
| Placebo | Placebo comparator | Drug: Zipalertinib Matching-placeboParticipants will receive zipalertinib matching-placebo, until the participant meets any of the treatment discontinuation criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Baseline imaging assessment of the brain (MRI [preferred modality] or CT scan) performed within 8 weeks prior to randomization must show no evidence of brain metastasis
- Complete surgical resection of the primary NSCLC is mandatory with negative surgical margins and systematic lymph node sampling or dissection.
- Complete recovery from surgery, including post-operative wound healing, and prior adjuvant chemotherapy (if applicable) at the time of randomization. Randomization timing is defined as follows:
Key exclusion criteria (18 listed)
- Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research.
- Treatment with any of the following within the time frame specified:
- Has received only wedge resections (complete anatomic segmentectomy is acceptable).
- Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis or any evidence of clinically active ILD/pneumonitis.
- Unable to swallow tablets or has any disease or condition that may significantly affect gastrointestinal (GI) absorption of zipalertinib (such as inflammatory bowel disease, malabsorption syndrome, or prior significant bowel resection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS6417Also: Zipalertinib, CLN-081Oral tablets. | Drug | Zipalertinib |
| Zipalertinib Matching-placeboOral tablets. | Drug | Placebo |
Primary outcome
Disease-free Survival (DFS) as Assessed by the Investigator
Time frame: Up to 5 years
11 secondary outcomes
Disease-free Survival Rate
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Overall Survival Rate
Time frame: Up to 5 years
DFS of Central Nervous System (cDFS)
Time frame: Up to 5 years
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time frame: Up to 5 years
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to 5 years
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to 5 years
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to 5 years
Number of Participants With Change in Left Ventricular Ejection Fraction (LVEF) Evaluated Using Electrocardiography (ECHO) and Multigated Acquisition (MUGA) Scan
Time frame: Up to 5 years
Change in EuroQuality of Life-5 Dimensional 3-Level (EQ-5D-3L)
Time frame: Baseline, up to 5 years
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scores
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
253 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAS6417 in people with Lung Cancer and Adjuvant, run by Taiho Oncology, Inc. at 253 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 253 sites in United States, Brazil, Italy, France, Japan and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taiho Oncology, Inc. (+1 844-878-2446, medicalinformation@taihooncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (DFS) as Assessed by the Investigator (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.