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

NCT ID: NCT07128199

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2032-10-01

Brief Summary

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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).

Detailed Description

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This study will evaluate zipalertinib, a novel EGFR tyrosine kinase inhibitor (TKI) in combination with standard platinum-based adjuvant chemotherapy versus placebo in combination with chemotherapy in participants with resected stage IB-IIIA NSCLC harboring uncommon EGFRmt.

Approximately 360 participants will be randomized 1:1 to:

Arm A: Platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed) in combination with zipalertinib 100 milligrams (mg) twice daily (BID), followed by zipalertinib 100 mg BID alone OR

Arm B: Platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed) in combination with placebo BID, followed by placebo BID alone.

The duration of 1 treatment cycle will be 21 days. An independent data monitoring committee (IDMC) will be established to monitor interim safety data.

Conditions

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NSCLC, Stage IB-IIIA Lung Cancer Adjuvant Post-surgical EGFR Exon 20 Early Stage Lung Cancer Uncommon EGFR Mutations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

IV infusion.

Carboplatin

Intervention Type DRUG

IV infusion.

Pemetrexed

Intervention Type DRUG

IV infusion.

TAS6417

Intervention Type DRUG

Oral tablets.

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.

Group Type PLACEBO_COMPARATOR

Cisplatin

Intervention Type DRUG

IV infusion.

Carboplatin

Intervention Type DRUG

IV infusion.

Pemetrexed

Intervention Type DRUG

IV infusion.

Zipalertinib Matching-placebo

Intervention Type DRUG

Oral tablets.

Interventions

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Cisplatin

IV infusion.

Intervention Type DRUG

Carboplatin

IV infusion.

Intervention Type DRUG

Pemetrexed

IV infusion.

Intervention Type DRUG

TAS6417

Oral tablets.

Intervention Type DRUG

Zipalertinib Matching-placebo

Oral tablets.

Intervention Type DRUG

Other Intervention Names

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Zipalertinib CLN-081

Eligibility Criteria

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Inclusion Criteria

1. Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.
2. 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:

1. exon20 insertion mutations (ex20ins) or
2. other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)
3. 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.
4. 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.
5. 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).
6. Complete recovery from surgery at the time of randomization.
7. Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1.
8. Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers.

Exclusion Criteria

1. Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study.
2. Treatment with any of the following within the time frame specified:

1. Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time.
2. Pre-operative or post-operative or planned radiation therapy for the current lung cancer.
3. Any prior systemic anticancer therapy (e.g., neoadjuvant chemotherapy), including investigational therapy, for treatment of NSCLC.
4. Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
5. All prescribed medication, over-the-counter medication, vitamin preparations and other food supplements, or herbal medications that are strong or moderate cytochrome p450 (CYP) 3A4 inducers or inhibitors within 7 days prior to first dose.
6. Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known.
3. Has received only segmentectomies or wedge resections.
4. Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis or any evidence of clinically active ILD/pneumonitis.
5. Impaired cardiac function or clinically significant cardiac disease.
6. 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).
7. Participants with a history of any other cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, other cancers curatively treated with no evidence of disease for \>5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
8. Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment. Screening not required.
9. Active bleeding disorders.
10. Known:

a. Hypersensitivity: i. To the ingredients in zipalertinib/placebo or any drugs similar in structure or class. ii. To platinum-containing drugs (i.e., cisplatin, carboplatin), pemetrexed, or any known excipients of these drugs. b. Contraindications to platinum-containing drugs (i.e., cisplatin, carboplatin) or pemetrexed according to the respective local labels.
11. Is unable or unwilling to take dexamethasone, folic acid, and/or vitamin B12 supplementation during treatment with pemetrexed.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taiho Oncology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alaska Oncology and Hematology

Anchorage, Alaska, United States

Site Status RECRUITING

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, United States

Site Status NOT_YET_RECRUITING

Georgetown University School of Medicine

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

Site Status NOT_YET_RECRUITING

D&H Cancer Research Center - Margate

Margate, Florida, United States

Site Status RECRUITING

Alpha Oncology Research

Orange City, Florida, United States

Site Status NOT_YET_RECRUITING

University of Illinois Medical Center

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Profound Research LLC at Michigan Hematology and Oncology Consultants

Dearborn, Michigan, United States

Site Status RECRUITING

Henry Ford Health System

Detroit, Michigan, United States

Site Status NOT_YET_RECRUITING

Perlmutter Cancer Center - 34th Street

New York, New York, United States

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center - New York

New York, New York, United States

Site Status NOT_YET_RECRUITING

Atrium Health Wake Forest Baptist - Comprehensive Cancer Center

Charlotte, North Carolina, United States

Site Status NOT_YET_RECRUITING

Gabrail Cancer and Research Center

Canton, Ohio, United States

Site Status RECRUITING

Virginia Cancer Specialists - Fairfax Office

Fairfax, Virginia, United States

Site Status NOT_YET_RECRUITING

Instituto Argentino de Diagnóstico y Tratamiento

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status NOT_YET_RECRUITING

Centro de Investigación Pergamino SA

Pergamino, Buenos Aires, Argentina

Site Status NOT_YET_RECRUITING

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Site Status NOT_YET_RECRUITING

CEMAIC - Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

Córdoba, , Argentina

Site Status NOT_YET_RECRUITING

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, Australia

Site Status NOT_YET_RECRUITING

GenesisCare - North Shore

St Leonards, New South Wales, Australia

Site Status NOT_YET_RECRUITING

Saint John of God - Subiaco Hospital

Subiaco, Western Australia, Australia

Site Status NOT_YET_RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Site Status NOT_YET_RECRUITING

Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg

Leuven, Flemish Brabant, Belgium

Site Status NOT_YET_RECRUITING

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

Fortaleza, Ceará, Brazil

Site Status NOT_YET_RECRUITING

Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Site Status NOT_YET_RECRUITING

Centro de Pesquisas Clínicas Em Oncologia - CPCO

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Site Status NOT_YET_RECRUITING

Hospital Santa Rita

Vitória, Espírito Santo, Brazil

Site Status NOT_YET_RECRUITING

Núcleo de Oncologia da Bahia Ondina - NOB

Salvador, Estado de Bahia, Brazil

Site Status NOT_YET_RECRUITING

Oncoclinicas Oncovida - Brasilia

Brasília, Federal District, Brazil

Site Status NOT_YET_RECRUITING

Cetus Oncologia - Unidade Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Site Status NOT_YET_RECRUITING

Cenantron Centro Avançado de Tratamento Oncológico

Belo Horizonte, Minas Gerais, Brazil

Site Status NOT_YET_RECRUITING

Centro Integrado de Oncologia de Curitiba (CIONC)

Curitiba, Paraná, Brazil

Site Status NOT_YET_RECRUITING

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Site Status NOT_YET_RECRUITING

Centro de Pesquisa Vencer e Oncoclínica - Teresina

Teresina, Piauí, Brazil

Site Status NOT_YET_RECRUITING

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

Botafogo, Rio de Janeiro, Brazil

Site Status NOT_YET_RECRUITING

Liga Contra o Câncer - Centro Avançado de Oncologia

Natal, Rio Grande do Norte, Brazil

Site Status NOT_YET_RECRUITING

Clínica Viver

Centro Santa Maria, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Hospital Bruno Born

Lajeado, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Hospital Mãe de Deus - Centro Integrado de Oncologia

Porto Alegre, Rio Grande do Sul, Brazil

Site Status NOT_YET_RECRUITING

Grupo ELORA

Florianópolis, Santa Catarina, Brazil

Site Status NOT_YET_RECRUITING

CHO Centro - Centro de Hematologia e Oncologia de Joinville

Joinville, Santa Catarina, Brazil

Site Status NOT_YET_RECRUITING

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

Barretos, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

Instituto de Oncologia de Sorocaba

Sorocaba, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

A Beneficência Portuguesa de São Paulo

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status NOT_YET_RECRUITING

William Osler Health System - Brampton Civic Hospital

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Hôpital Saint-André

Bordeaux, Aquitane, France

Site Status NOT_YET_RECRUITING

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Lyon-Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Site Status NOT_YET_RECRUITING

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

Villefranche-de-Rouergue, Aveyron, France

Site Status NOT_YET_RECRUITING

Hôpital Côte De Nacre

Caen, Basse-Normandie, France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Site Status NOT_YET_RECRUITING

Hôpital Emile Muller

Mulhouse, Grand Est, France

Site Status NOT_YET_RECRUITING

Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

Saint-Herblain, Loire-Atlantique, France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire d'Angers

Angers, Maine-et-Loire, France

Site Status NOT_YET_RECRUITING

CHU d Angers

Angers, Maine-et-Loire, France

Site Status RECRUITING

Institut de Cancérologie de l'Ouest - Angers

Angers, Maine-et-Loire, France

Site Status NOT_YET_RECRUITING

CHU de Nimes - Caremeau Nord

Nîmes, Occitanie, France

Site Status RECRUITING

Centre Hospitalier Le Mans

Le Mans, Pays de la Loire Region, France

Site Status NOT_YET_RECRUITING

Hopital Prive du Confluet

Nantes, Pays de la Loire Region, France

Site Status RECRUITING

Hôpital Privé du Confluent

Nantes, Pays de la Loire Region, France

Site Status NOT_YET_RECRUITING

Hopital Nord Ouest

Gleizé, Rhône, France

Site Status RECRUITING

Gustave Roussy

Villejuif, , France

Site Status NOT_YET_RECRUITING

Hôpital Ambroise-Paré

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

Site Status NOT_YET_RECRUITING

Centre Hospitalier Intercommunal de Créteil

Créteil, Île-de-France Region, France

Site Status NOT_YET_RECRUITING

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, France

Site Status NOT_YET_RECRUITING

Hôpital Bichat - Claude-Bernard

Paris, Île-de-France Region, France

Site Status NOT_YET_RECRUITING

SLK-Kliniken - Fachklinik Löwenstein

Löwenstein, Baden-Wurttemberg, Germany

Site Status NOT_YET_RECRUITING

Krankenhaus Nordwest

Frankfurt am Main, Hesse, Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Gießen und Marburg - Gießen

Giessen, Hesse, Germany

Site Status NOT_YET_RECRUITING

Kliniken der Stadt Köln

Cologne, North Rhine-Westphalia, Germany

Site Status NOT_YET_RECRUITING

Saint Savvas Anticancer - Oncological Hospital of Athens

Athens, Attica, Greece

Site Status NOT_YET_RECRUITING

General Hospital for Thoracic Diseases Sotiria

Athens, Attica, Greece

Site Status NOT_YET_RECRUITING

Metaxa Cancer Hospital of Piraeus

Athens, Attica, Greece

Site Status NOT_YET_RECRUITING

BioClinic Thessaloniki

Athens, Central Macedonia, Greece

Site Status NOT_YET_RECRUITING

Interbalkan Medical Center of Thessaloniki

Thessaloniki, Central Macedonia, Greece

Site Status NOT_YET_RECRUITING

Humanity & Health Clinical Trial Centre

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Queen Mary Hospital - Hong Kong

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Princess Margaret Hospital

Kowloon, , Hong Kong

Site Status NOT_YET_RECRUITING

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

Meldola, Forlì-Cesena, Italy

Site Status NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale (ASST) di Bergamo Ovest

Legnano, Milan, Italy

Site Status NOT_YET_RECRUITING

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Milan, Italy

Site Status NOT_YET_RECRUITING

Istituto Europeo di Oncologia

Milan, Milan, Italy

Site Status NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Milan, Italy

Site Status NOT_YET_RECRUITING

Ospedale del Mare

Napoli, Naples, Italy

Site Status NOT_YET_RECRUITING

Ospedale Santa Maria delle Croci di Ravenna

Lugo, Ravenna, Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata

Roma, Rome, Italy

Site Status NOT_YET_RECRUITING

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia

Candiolo, Torino, Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, Torino, Italy

Site Status NOT_YET_RECRUITING

Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, Italy

Site Status NOT_YET_RECRUITING

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

Alessandria, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Delle Marche

Ancona, , Italy

Site Status RECRUITING

Humanitas Gavazzeni

Bergamo, , Italy

Site Status NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII

Bergamo, , Italy

Site Status NOT_YET_RECRUITING

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

Bologna, , Italy

Site Status NOT_YET_RECRUITING

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

Catania, , Italy

Site Status NOT_YET_RECRUITING

Azienda Unita Sanitaria Locale toscana Nord Ovest

Livorno, , Italy

Site Status RECRUITING

Azienda Unità Sanitaria Locale Toscana Nord Ovest

Livorno, , Italy

Site Status NOT_YET_RECRUITING

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

Milan, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero - Universitaria di Modena

Modena, , Italy

Site Status NOT_YET_RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status NOT_YET_RECRUITING

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

Siena, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status NOT_YET_RECRUITING

Aichi Cancer Center

Nagoya, Aiti [Aichi], Japan

Site Status NOT_YET_RECRUITING

Kurume University Hospital

Kurume-Shi, Fukuoka, Japan

Site Status NOT_YET_RECRUITING

Hiroshima University Hospital

Hiroshima, Hirosima [Hiroshima], Japan

Site Status RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, Hukuoka [Fukuoka], Japan

Site Status RECRUITING

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Site Status RECRUITING

Kobe University Hospital

Kobe, Hyōgo, Japan

Site Status NOT_YET_RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status NOT_YET_RECRUITING

Tohoku University Hospital

Sendai, Miyagi, Japan

Site Status NOT_YET_RECRUITING

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

Site Status NOT_YET_RECRUITING

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Site Status NOT_YET_RECRUITING

Kindai University Hospital

Osakasayama-Shi, Osaka, Japan

Site Status RECRUITING

Shizuoka Cancer Center

Sunto-gun, Sizuoka [Shizuoka], Japan

Site Status NOT_YET_RECRUITING

National Cancer Center Hospital East

Kashiwa-shi, Tiba [Chiba], Japan

Site Status NOT_YET_RECRUITING

Cancer Institute Hospital of JFCR

Koto, Tokyo, Japan

Site Status RECRUITING

Okayama University Hospital

Okayama, , Japan

Site Status NOT_YET_RECRUITING

Osaka City General Hospital

Osaka, , Japan

Site Status RECRUITING

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, , Japan

Site Status NOT_YET_RECRUITING

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Site Status NOT_YET_RECRUITING

Hospital Pulau Pinang

Pulau Pinang, Pulau Pinang, Malaysia

Site Status NOT_YET_RECRUITING

Hospital Picaso

Petaling Jaya, Selangor, Malaysia

Site Status NOT_YET_RECRUITING

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status NOT_YET_RECRUITING

Sunway Medical Centre

Selangor Darul Ehsan, , Malaysia

Site Status NOT_YET_RECRUITING

Preparaciones Oncológicas S.C.

León, Guanajuato, Mexico

Site Status NOT_YET_RECRUITING

Centro Oncológico Alianza XXI

Mexico City, Mexico City, Mexico

Site Status NOT_YET_RECRUITING

Clínica Integral Internacional de Oncología S de RL de CV

Mirador, Puebla, Mexico

Site Status NOT_YET_RECRUITING

Ziekenhuis St Jansdal Harderwijk

Harderwijk, Gelderland, Netherlands

Site Status NOT_YET_RECRUITING

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, Netherlands

Site Status NOT_YET_RECRUITING

Leids Universitair Medisch Centrum (LUMC)

Leiden, South Holland, Netherlands

Site Status NOT_YET_RECRUITING

Hospital Nacional Arzobispo Loayza

Lima Cercado, Lima region, Peru

Site Status NOT_YET_RECRUITING

IPOR - Instituto Peruano de Oncología & Radioterapia - Sede Principal

San Isidro, Lima region, Peru

Site Status NOT_YET_RECRUITING

Detecta Clínica

Surquillo, Lima region, Peru

Site Status NOT_YET_RECRUITING

Przychodnia Lekarska KOMED Roman Karaszewski

Konin, Greater Poland Voivodeship, Poland

Site Status NOT_YET_RECRUITING

4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status NOT_YET_RECRUITING

Mruk-Med I Sp. z o.o.

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status RECRUITING

Warmińsko-mazurskie Centrum Chorób Płuc w Olsztynie

Olsztyn, Warmian-Masurian Voivodeship, Poland

Site Status NOT_YET_RECRUITING

Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej

Biała Podlaska, , Poland

Site Status NOT_YET_RECRUITING

Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu

Bucharest, Bucharest, Romania

Site Status NOT_YET_RECRUITING

Monza Oncology Day Hospital

Bucharest, București, Romania

Site Status NOT_YET_RECRUITING

Centrul de Radioterapie Amethyst Cluj

Floreşti, Cluj, Romania

Site Status NOT_YET_RECRUITING

Ovidius Clinical Hospital

Ovidiu, Constanța County, Romania

Site Status NOT_YET_RECRUITING

Clinica MC Gral Ploiesti

Ploieşti, Prahova, Romania

Site Status NOT_YET_RECRUITING

Oncocenter - Oncologie Clinica

Timișoara, Timiș County, Romania

Site Status NOT_YET_RECRUITING

Spitalul Județean de Urgență Satu Mare

Satu Mare, , Romania

Site Status NOT_YET_RECRUITING

Tan Tock Seng Hospital

Singapore, North East, Singapore

Site Status NOT_YET_RECRUITING

National Cancer Centre Singapore

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea

Site Status NOT_YET_RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status NOT_YET_RECRUITING

Catholic University of Korea St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Site Status NOT_YET_RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Site Status NOT_YET_RECRUITING

Chungbuk National University Hospital

Cheongju-si, Gyeonggido [Kyonggi-do], South Korea

Site Status NOT_YET_RECRUITING

National Cancer Center - Korea

Goyang-si, Gyeonggido [Kyonggi-do], South Korea

Site Status NOT_YET_RECRUITING

Keimyung University Dongsan Hospital

Daegu, Gyeongsangbugdo [Kyongsangbuk-do], South Korea

Site Status NOT_YET_RECRUITING

Kosin University Gospel Hospital

Pusan, Gyeongsangnam-do, South Korea

Site Status NOT_YET_RECRUITING

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status NOT_YET_RECRUITING

Gyeongsang National University Hospital

Jinju, Gyeongsangnamdo [Kyongsangnam-do], South Korea

Site Status NOT_YET_RECRUITING

Inha University Hospital

Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], South Korea

Site Status NOT_YET_RECRUITING

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

Site Status NOT_YET_RECRUITING

Jeonbuk National University Hospital

Jeonju, Jeonrabugdo [Chollabuk-do], South Korea

Site Status NOT_YET_RECRUITING

Korea University Anam Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Site Status NOT_YET_RECRUITING

Severance Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Site Status NOT_YET_RECRUITING

Konkuk University Medical Center

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Site Status NOT_YET_RECRUITING

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

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Site Status NOT_YET_RECRUITING

Korea University Guro Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Site Status NOT_YET_RECRUITING

Hanyang University Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Site Status NOT_YET_RECRUITING

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Site Status NOT_YET_RECRUITING

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Site Status NOT_YET_RECRUITING

Institut Català d'Oncologia Badalona

Badalona, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Site Status NOT_YET_RECRUITING

Instituto Oncológico Dr Rosell

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Clínico San Cecilio PTS

Granada, , Spain

Site Status RECRUITING

Hospital Universitario Lucus Augusti

Lugo, , Spain

Site Status NOT_YET_RECRUITING

MD Anderson Cancer Center Madrid

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Quirónsalud Málaga

Málaga, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Chulabhorn Hospital

Bang Kapi, Bangkok, Thailand

Site Status NOT_YET_RECRUITING

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status NOT_YET_RECRUITING

Lampang Cancer Hospital

Muang, Changwat Lampang, Thailand

Site Status NOT_YET_RECRUITING

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, Thailand

Site Status NOT_YET_RECRUITING

Navamindradhiraj University - Faculty of Medicine Vajira Hospital

Bangkok, Khet Dusit, Thailand

Site Status NOT_YET_RECRUITING

Başkent Üniversitesi Adana Dr Turgut Noyan Uygulama ve Araştirma Merkezi

Yüreğir, Adana, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi

Etlik, Ankara, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Dicle Üniversitesi Tıp Fakültesi

Sur, Diyarbakır, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Gaziantep Universitesi - Şahinbey Araştırma ve Uygulama Hastanesi

Şehitkamil, Gaziantep, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Memorial Bahçelievler Hospital

Bahçelievler, Istanbul, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

İstinye Üniversite Hastanesi Liv Hospital Bahcesehir

Esenyurt, Istanbul, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

İ.A.Ü. VM Medical Park Florya Hastanesi

Küçükçekmece, Istanbul, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Medicana International Izmir Hastanesi

Turgutlu, Manisa, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

VM Medical Park Samsun Hastanesi

Atakum, Samsun, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Medical Park Seyhan Hastanesi

Adana, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

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

Adana, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Liv Hospital Ankara

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi

Edirne, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Ozel Gaziantep Medical Point Hastanesi

Gaziantep, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

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

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

The Christie NHS Foundation Trust

Manchester, England, United Kingdom

Site Status NOT_YET_RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, England, United Kingdom

Site Status NOT_YET_RECRUITING

Velindre University NHS Trust

Cardiff, Wales, United Kingdom

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Brazil Canada France Germany Greece Hong Kong Italy Japan Malaysia Mexico Netherlands Peru Poland Romania Singapore South Korea Spain Thailand Turkey (Türkiye) United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Taiho Oncology INC

Role: CONTACT

Phone: +1 844-878-2446

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-521775-31-00

Identifier Type: OTHER

Identifier Source: secondary_id

TAS6417-302

Identifier Type: -

Identifier Source: org_study_id