Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo shows promise for rare lung cancer mutation

NCT ID NCT05973773

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests whether adding the experimental drug zipalertinib to standard chemotherapy works better than chemotherapy alone for people with advanced non-small cell lung cancer that has a specific genetic change (EGFR exon 20 insertion). About 285 adults who have not had prior treatment for their advanced cancer will take part. The main goals are to see if the combination slows cancer growth and to check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

285 people

The number who actually took part.

Started

Dec 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion- 1. Provide written informed consent. 2. ≥18 years of age (or meets the country's regulatory definition for legal adult age, whichever is greater). 3. Pathologically confirmed, locally advanced or metastatic nonsquamous NSCLC 4. Has not received any prior systemic treatment for their locally advanced or metastatic nonsquamous NSCLC. Prior adjuvant/neoadjuvant treatment received \>6 months prior to first dose of study treatment is allowed for early-stage NSCLC. Prior monotherapy with an approved EGFR TKI (ie, gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib) as nonstandard first-line therapy for the treatment of locally advanced or metastatic disease is allowed if all of the following criteria are met: 1. Treatment duration did not exceed 8 weeks; 2. Lack of disease response was documented (radiographically) by an increase in tumor burden (a copy of the computerized tomography \[CT\] report showing increase in tumor burden from baseline should be submitted); 3. Associated toxicities have resolved to baseline; and 4. The EGFR TKI was discontinued at least 2 weeks or 4 half-lives prior to randomization, whichever is longer. Prior therapy with EGFR TKI agents targeting exon20ins mutations including amivantamab, mobocertinib, sunvozertinib, furmonertinib, and poziotinib is not allowed. 5. Documented EGFR mutation status, as determined by local testing performed at a CLIA certified (US) or accredited (outside of the US) local laboratory, defined as follows: 1. Part A: EGFR ex20ins or other uncommon single or compound EGFR mutation 2. Part B: EGFR ex20ins mutation 6. Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFR mutation status and, where possible, other biomarkers. Patients with insufficient tissue (details provided in laboratory manual) may be eligible following discussion with the sponsor; a fresh biopsy will not be required. 7. Patients with brain metastasis(es) who have previously received definitive local treatment and have stable central nervous system (CNS) disease (defined as being neurologically stable and off corticosteroid for at least 2 weeks prior to enrollment) are eligible. If brain metastases are diagnosed on screening imaging, the patient may be rescreened for eligibility after definitive treatment. b. Asymptomatic brain metastases ≤2 cm in size can be eligible for inclusion if, in the opinion of the Investigator, immediate definitive treatment is not indicated. 8. At least one measurable lesion as determined per RECIST 1.1 for patients enrolling to Part B. Patients enrolling to Part A may be enrolled without measurable disease. 9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 10. Adequate organ function, as defined by the laboratory value 11. Have a life expectancy of at least 3 months as assessed by the investigator. 12. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to administration of the first dose of study treatment. Female patients are not considered to be of childbearing potential if they are postmenopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). 13. Both males and females of reproductive potential must agree to use effective birth control during the study prior to the first dose and for 6 months after the last dose of study treatment or longer, based on local requirements. Exclusion - 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. Prior treatment with any of the following within the specific time frame specified: 1. Zipalertinib (TAS6417/CLN-081) at any time. 2. Thoracic radiotherapy ≤28 days, palliative radiation of nonthoracic disease ≤14 days, or palliative radiation of a single lesion ≤7 days prior to first dose of study treatment. 3. Major surgery (excluding placement of vascular access) ≤28 days prior to first dose of study treatment. 4. All prescribed medication, over-the-counter medication, vitamin preparations and other food supplements, or herbal medications that are strong or moderate CYP3A4 inducers or inhibitors within 7 days prior to first dose. 3. Have any unresolved toxicity of Grade ≥2 from previous anticancer treatment in the neoadjuvant or adjuvant setting, except for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the investigator and Sponsor. 4. Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or any evidence of clinically active interstitial lung disease. 5. Impaired cardiac function or clinically significant cardiac disease, including any of the following: 1. History of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification . 2. Serious cardiac arrhythmias requiring treatment. 3. Resting corrected QT interval (QTc) \>470 msec calculated using Fridericia's formula (QTcF). 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 GI resection). 7. History of another primary malignancy ≤2 years prior to the date of first dose of study treatment unless at least one of the following criteria are met: 1. Adequately treated basal or squamous cell carcinoma of the skin 2. Cancer of the breast or cervix in situ 3. Previously treated malignancy, if all treatment for that malignancy was completed at least 2 years prior to first dose of study treatment, and no current evidence of disease 4. Concurrent malignancy determined to be clinically stable and not requiring tumor directed treatment 8. Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment. 9. History of COVID-19 infection within 4 weeks prior to enrolment and/or have persistent, clinically significant pulmonary symptoms related to prior COVID-19 infection. 10. Active bleeding disorders. 11. Known hypersensitivity to the ingredients in zipalertinib or any drugs similar in structure or class. To platinum-containing drugs (ie, cisplatin, carboplatin), pemetrexed, or any known excipients of these drugs. b. Contraindications toning drugs (ie, cisplatin, carboplatin) or pemetrexed according to the respective local labels. 12. History of leptomeningeal disease and spinal cord compression. 13. Is unable or unwilling to take dexamethasone, folic acid, and/or vitamin B12 supplementation during treatment with pemetrexed. 14. Is pregnant or lactating or planning to become pregnant 15. The patient is, in the investigator's opinion, unable or unwilling to comply with the trial procedures.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced or metastatic NSCLS with exon 20 insertion mutation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

lung disorder non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic NSCLS with exon 20 insertion mutation

Contacts and locations

Locations

  • Actualidad Basada en la Investigación del Cáncer

    Guadalajara, Jalisco, 44680, Mexico

  • Aichi Cancer Center

    Nagoya, Aiti [Aichi], 464-8681, Japan

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Algemeen Ziekenhuis Delta - Campus Menen

    Menen, West Flanders, 8930, Belgium

  • Algemeen Ziekenhuis Delta - Campus Rumbeke

    Rosières, West-Vlaanderen, 8800, Belgium

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, Oost-Vlaaderen, 9000, Belgium

  • Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi

    Etlik, Etlik, 06010, Turkey (Türkiye)

  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara, Jalisco, 44280, Mexico

  • Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Asian Hospital and Medical Center

    City of Muntinlupa, 1780, Philippines

  • Asklepios Klinik Altona

    Hamburg, Hamburg (Hansestadt), 22763, Germany

  • Assuta Hospital - Ramat HaHayal

    Tel Aviv, Tel Aviv, 69710, Israel

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, Verona, 37126, Italy

  • Azienda Ospedaliero - Universitaria di Modena

    Modena, Modena, 41224, Italy

  • Azienda Unità Sanitaria Locale della Romagna

    Ravenna, Ravenna, 48121, Italy

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, Istanbul, 34214, Turkey (Türkiye)

  • BioClinic Thessaloniki

    Thessaloniki, Thessaloniki, 54622, Greece

  • CH Cornouaille Quimper

    Quimper, 29000, France

  • Cancer Institute Hospital of JFCR

    Koto, Tokyo, 135-8550, Japan

  • Catholic University of Korea Saint Vincent's Hospital

    Suwon, Gyeonggi-do, 16247, South Korea

  • Centre Hospitalier Le Mans

    Le Mans, Pays de la Loire Region, 72037, France

  • Centre Hospitalier Universitaire Limoges

    Limoges, Limousin, 87042, France

  • Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60335-480, Brazil

  • CentroEstudiosClinicosSAGA

    Santiago, Region de Santiago, 7500653, Chile

  • Centrul de Oncologie Sf Nectarie

    Craiova, Dolj, 200746, Romania

  • Clinica SIGMedical

    Suceava, Suceava, 720214, Romania

  • Clínica Integral Internacional de Oncología S de RL de CV

    Mirador, Puebla, 72530, Mexico

  • Clínica Mi Tres Torres

    Barcelona, Barcelona, 08017, Spain

  • Clínica Neoplasias Litoral

    Itajaí, Santa Catatina, 88301, Brazil

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006, Spain

  • Comprehensive Cancer Centers of Nevada - Central Valley - Twain

    Las Vegas, Nevada, 89169, United States

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052, United States

  • Comprehensive Cancer Centers of Nevada - Horizon Ridge Henderson

    Henderson, Nevada, 89052, United States

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89218, United States

  • Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie

    Henderson, Nevada, 89074, United States

  • Comprehensive Cancer Centers of Nevada - Southwest

    Las Vegas, Nevada, 89148, United States

  • Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II

    Las Vegas, Nevada, 89144, United States

  • Emek Medical Center

    Afula, 18101, Israel

  • FAICIC Clínical Research

    Veracruz, Veracruz, 91900, Mexico

  • Faculty of Medicine Siriraj Hospital

    Bang Phlat, Bangkok, 10700, Thailand

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Pavia, 27100, Italy

  • Gabrail Cancer and Research Center

    Canton, Ohio, 44718, United States

  • General Hospital for Thoracic Diseases Sotiria

    Athens, Attica, 11527, Greece

  • Gustave Roussy

    Villejuif, Val-de-Marne, 94805, France

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnamdo [Kyongsangnam-do], 52727, South Korea

  • Hacettepe Üniversitesi Kanser Enstitüsü

    Ankara, Ankara, 06010, Turkey (Türkiye)

  • Hadassah University Hospital Ein Kerem

    Jerusalem, Jerusalem, 9112001, Israel

  • Health Pharma Professional Research S.A. De C.V

    Mexico City, Mexico City, 3100, Mexico

  • Hirosaki University Hospital

    Hirosaki-Shi, Aomori, 036-8563, Japan

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-180, Brazil

  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036, Spain

  • Hospital Clínico Universidad de Chile

    Independencia, Santiago Metropolitan, 8380494, Chile

  • Hospital Mãe de Deus - Centro Integrado de Oncologia

    Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

  • Hospital Quirónsalud Barcelona

    Barcelona, Barcelona, 08023, Spain

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga, Málaga, 29010, Spain

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046, Spain

  • Hospital Universitario de Jaén

    Jaén, 23007, Spain

  • Hôpital Ambroise-Paré

    Boulogne-Billancourt, Île-de-France Region, 92100, France

  • Hôpital Côte De Nacre

    Caen, Basse-Normandie, 14033, France

  • Hôpital Haut-Lévêque

    Pessac, New Aquitaine, 33604, France

  • IRCCS Istituto Nazionale Tumori Regina Elena

    Roma, Roma, 1444, Italy

  • Icon Cancer Centre - Mount Alvernia

    Singapore, 228510, Singapore

  • Icon Cancer Centre Mount Elizabeth

    Singapore, 574623, Singapore

  • Inha University Hospital

    Incheon, Incheon Gwang'Yeogsi [Inch'On-Kwangyokshi], 22332, South Korea

  • Institut Curie

    Paris, Île-de-France Region, 75248, France

  • Instituto Oncológico Fundación Arturo López Pérez

    Providencia, Santiago Metropolitan, 7500921, Chile

  • Instytut MSF

    Lodz, Lódzkie, 90-302, Poland

  • Investigacion Medica Galerias

    Aguascalientes, Aguascalientes, 20124, Mexico

  • Istituto Nazionale per la Ricerca sul Cancro

    Genova, Genoa, 16132, Italy

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

    Meldola, Forli-Cesena, 47014, Italy

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

    Meldola, Forlì-Cesena, 47014, Italy

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

    Milan, Milan, 20132, Italy

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051, Japan

  • Kanazawa University Hospital

    Kanazawa, 920-8641, Japan

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191, Japan

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582, Japan

  • King Chulalongkorn Memorial Hospital

    Pathum Wan, Bangkok, 10330, Thailand

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375, Japan

  • Korea University Anam Hospital

    Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 02841, South Korea

  • Korea University Guro Hospital

    Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 08308, South Korea

  • Kyushu Cancer Center

    Fukuoka, Hukuoka, 811-1395, Japan

  • LMU Klinikum - Campus Innenstadt

    München, 80337, Germany

  • Les Hôpitaux Universitaires de Strasbourg

    Strasbourg, Alsace, 67091, France

  • MD Anderson Cancer Center Madrid

    Madrid, Madrid, 28033, Spain

  • Medical Park Seyhan Hastanesi

    Adana, Adana, 01120, Turkey (Türkiye)

  • Medisprof

    Cluj-Napoca, Cluj, 400641, Romania

  • Memorial Ankara Hastanesi

    Ankara, Ankara, 6520, Turkey (Türkiye)

  • Metropolitan General

    Piraeus, Attica, 18547, Greece

  • Metropolitan Hospital

    Piraeus, Pireas, 185 47, Greece

  • Multi-profile Hospital for Active Treatment Uni Hospital

    Panagyurishte, Pazardzhik, 1527, Bulgaria

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai-Shi, Osaka, 591-8555, Japan

  • Navamindradhiraj University - Faculty of Medicine Vajira Hospital

    Bangkok, Khet Dusit, 10300, Thailand

  • Nottingham University Hospitals NHS Trust

    Nottingham, England, NG5 1PB, United Kingdom

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Oncocare Cancer Centre

    Singapore, 308900, Singapore

  • Oncocenter - Oncologie Clinica

    Timișoara, Timiș County, 300166, Romania

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021, Japan

  • Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Radboud Universitair Medisch Centrum

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Royal Free London NHS Foundation Trust

    London, England, NW3 2QG, United Kingdom

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4163, Japan

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, Lublin Voivodeship, 20-954, Poland

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873, Japan

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • St. Luke's Medical Center - Quezon City

    Quezon City, Metropolitan Manila, 1112, Philippines

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

    Istanbul, Istanbul, 34722, Turkey (Türkiye)

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

    Adana, Adana, 01060, Turkey (Türkiye)

  • T.C. Saglik Bakanligi Ankara Bilkent Sehi?r Hastanesi?

    Çankaya, Çankaya, 06800, Turkey (Türkiye)

  • Tan Tock Seng Hospital

    Singapore, 30433, Singapore

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The Medical City

    Pasig, National Capital Region, 1605, Philippines

  • Torbay and South Devon NHS Foundation Trust

    Torquay, England, TQ2 7AA, United Kingdom

  • Trakya Üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi

    Edirne, Edirne, 22130, Turkey (Türkiye)

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Flemish Brabant, 3000, Belgium

  • University General Hospital of Larissa

    Larissa, Thessaly, 41110, Greece

  • University General Hospital of Patras

    Patra, Peloponnese, 26504, Greece

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL

    Sofia, Sofia, 4500, Bulgaria

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Universitätsklinikum Gießen und Marburg - Gießen

    Giessen, Hesse, 35392, Germany

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • Vrije Universiteit Medisch Centrum

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

    Pozna?, Greater Poland Voivodeship, 60-569, Poland

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7, Canada