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 pill zongertinib takes on HER2 lung cancer in major trial

NCT ID NCT06151574

Disease control Sponsor: Boehringer Ingelheim 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This Phase 3 trial tests whether the oral drug zongertinib can slow cancer growth better than standard chemotherapy plus immunotherapy in people with advanced HER2-mutant non-small cell lung cancer. About 428 adults who have not had prior treatment for advanced disease will be randomly assigned to receive either zongertinib pills or standard infusions. The study will compare how long it takes for the cancer to worsen and track side effects and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zongertinib (a pill that targets HER2 mutations)
What this could lead to
If it works, zongertinib could offer a more effective, targeted first-line treatment for people with HER2-mutant lung cancer, potentially slowing tumor growth and extending life.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The drug may not work better than current chemotherapy plus immunotherapy, and side effects are still being studied.

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

428 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Jan 2028

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 criteria: 1. Signed and dated written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. 2. Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF. 3. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous Non-small cell lung cancer (NSCLC). 4. Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results. 5. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status. If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor. 6. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy. 7. Presence of at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology assessment. 8. Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the Summaries of Product Characteristics (SmPC)/Product Information. Further inclusion criteria apply. Exclusion criteria: 1. Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except; * effectively treated non-melanoma skin cancers * effectively treated carcinoma in situ of the cervix * effectively treated ductal carcinoma in situ * other effectively treated malignancy that is considered cured by local treatment 2. Tumors with targetable alterations with approved available therapy. 3. Lung-specific intercurrent clinically significant severe illness based on investigators assessment. 4. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. 5. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening, e.g. hip replacement. 6. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug. 7. History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization. 8. Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block. Further exclusion criteria apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Lung cancer, non-squamous, non-small cell are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Lung cancer, non-squamous, non-small cell

Contacts and locations

Locations

  • A. O. Ospedale Circolo Fond. Macchi

    Varese, 21100, Italy

  • AOU Policlinico Umberto I

    Roma, 00161, Italy

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681, Japan

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Associacao Dr. Bartholomeu Tacchini

    Bento Gonçalves, 95700-084, Brazil

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera Unversitaria di Parma

    Parma, 43100, Italy

  • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania

    Catania, 95123, Italy

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Bradford Hill- Centro de Investigacion Clinica

    Recoleta, 8420383, Chile

  • Brussels - HOSP Jules Bordet

    Anderlecht, 1070, Belgium

  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

    Santo André, 09060-650, Brazil

  • CTR Leon Berard

    Lyon, 69373, France

  • Cancer Care Specialists

    Reno, Nevada, 89511, United States

  • Cancer Hospital of Chinese Academy of Medical Science

    Beijing, 1000021, China

  • Carolina Blood and Cancer Care Associates, PA

    Rock Hill, South Carolina, 29732, United States

  • Centro Hospitalar Lisboa Norte Hospital Pulido Valente

    Lisbon, 1769-001, Portugal

  • Centro Oncologico Personalizado

    México, 06760, Mexico

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE, Argentina

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 330, Taiwan

  • Chung Shan Medical University Hospital

    Taichung, 404, Taiwan

  • Chungbuk National University Hospital

    Cheongiu, 28644, South Korea

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805, United States

  • ClinRé 001-022 (Premier Cancer Care and Infusion Center)

    Fresno, California, 93710, United States

  • Clinic Floridsdorf

    Vienna, 1210, Austria

  • Clinica Adventista Belgrano

    CABA, 1430, Argentina

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006, Spain

  • FAICIC S de RL de C.V.

    Veracruz, 91900, Mexico

  • First Affiliated Hospital of Xiamen University

    Xiamen, 361003, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Fujian Cancer Hospital

    Fuzhou, 350014, China

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, 15090-000, Brazil

  • Gabrail Cancer Center

    Canton, Ohio, 44718, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gemeinschaftskrankenhaus Havelhöhe gGmbH

    Berlin, 14089, Germany

  • Greater Poland Center of Pulmonology and Thoracic Surgery

    Poznan, 60-569, Poland

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • HOP Civil

    Strasbourg, 67091, France

  • HOP Nord

    Marseille, 13015, France

  • HOP Pontchaillou

    Rennes, 35000, France

  • HOP Tenon

    Paris, 75020, France

  • Hakodate Goryoukaku Hospital

    Hokkaido, Hakodate, 040-8611, Japan

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

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

    Mexico City, 03100, Mexico

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hirosaki University Hospital

    Aomori, Hirosaki, 036-8563, Japan

  • Hokkaido Cancer Center

    Hokkaido, Sapporo, 003-0804, Japan

  • Hospital CUF Porto

    Porto, 4100-180, Portugal

  • Hospital CUF Tejo

    Lisbon, 1350-352, Portugal

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Regional Universitario de Málaga

    Málaga, 29010, Spain

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Virgen del Rocío

    Seville, 41013, Spain

  • Hospital de Basurto

    Bilbao, 48013, Spain

  • Hospital do Câncer de Londrina

    Londrina, 86015-520, Brazil

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Hôpital Larrey - CHU de Toulouse

    Toulouse, 31059, France

  • Hôpital Louis Pradel

    Bron, 69677, France

  • ICESP - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246-000, Brazil

  • INS Curie

    Paris, 75248, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autónoma de Bs As, C1426ANZ, Argentina

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, S2000DEJ, Argentina

  • Instituto Nacional de Cancerologia

    México, 14080, Mexico

  • Instituto Oncologico de Cordoba

    Córdoba, X5000, Argentina

  • Istituto Di Candiolo

    Candiolo (TO), 10060, Italy

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    Naples, 80131, Italy

  • Istituto Tumori Giovanni Paolo II

    Bari, 70124, Italy

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550, Japan

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 113-8431, Japan

  • Justus-Liebig Universität Gießen

    Giessen, 35392, Germany

  • Kanagawa Cancer Center

    Kanagawa, Yokohama, 241-8515, Japan

  • Kanazawa University Hospital

    Ishikawa, Kanazawa, 920-8641, Japan

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76, Sweden

  • Komagome Hospital

    Tokyo, Bunkyo-ku, 113-8677, Japan

  • Krems University Hospital

    Krems, 3500, Austria

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • MED POLONIA SP Z O O, Clinical Trials Department,Poznan

    Poznan, 60693, Poland

  • Maastricht University Medisch Centrum

    Maastricht, 6229 HX, Netherlands

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • National Cancer Center

    Goyang, 10408, South Korea

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577, Japan

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • National Taiwan University Cancer Center

    Taipei, 106, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • National University Hospital-Singapore-22806

    Singapore, 119228, Singapore

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)

    Amsterdam, 1066 CX, Netherlands

  • Northwell Health

    Lake Success, New York, 11042, United States

  • OPN Healthcare, Inc.

    Glendale, California, 91203, United States

  • Okayama University Hospital

    Okayama, Okayama, 700-8558, Japan

  • OncoClinicas Rio de Janeiro

    Rio de Janeiro, 22250-040, Brazil

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw, 02-781, Poland

  • Oncology Hematology Associates

    Springfield, Missouri, 65807, United States

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, 0379, Norway

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935, Puerto Rico

  • Pioneer Research Center - Bullhead City

    Bullhead City, Arizona, 86442, United States

  • Pius-Hospital, Oldenburg

    Oldenburg, 26121, Germany

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz, 93-338, Poland

  • Precision NextGen Oncology

    Beverly Hills, California, 90212, United States

  • Prince of Wales Hospital-Randwick-66496

    Randwick, New South Wales, 2031, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Hospital

    Hong Kong, 999077, Hong Kong

  • Queen Elizabeth Hospital-Hong Kong-51727

    Hong Kong, 51727, Hong Kong

  • Queen Mary Hospital

    Hong Kong, 999077, Hong Kong

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Regional Medical Oncology Center

    Wilson, North Carolina, 27893, United States

  • Royal North Shore Hospital-St Leonards-20807

    St Leonards, New South Wales, 2065, Australia

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • Sahlgrenska Universitetsjukhuset

    Gothenburg, 413 45, Sweden

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Scripps Green Hospital

    La Jolla, California, 92037, United States

  • Severance Hospital

    Seoul, 03722, South Korea

  • Sharp Memorial Hospital

    San Diego, California, 92123, United States

  • Shikoku Cancer Center

    Ehime, Matsuyama, 791-0280, Japan

  • Shizuoka Cancer Center

    Shizuoka, Sunto-gun, 411-8777, Japan

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, 310016, China

  • Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008, Australia

  • St. Louis Cancer Care, LLP

    Bridgeton, Missouri, 63044, United States

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511, Japan

  • Swedish Cancer Institute

    Edmonds, Washington, 98026, United States

  • Swedish Cancer Institute

    Issaquah, Washington, 98029, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317099, China

  • The Catholic University of Korea, St.Vincent's Hospital

    Suwon, 16247, South Korea

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000, China

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, 310003, China

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden Hospital, Sutton

    Sutton, SM2 5PT, United Kingdom

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126, Germany

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574, Japan

  • UZ Leuven

    Leuven, 3000, Belgium

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566, Japan

  • Universitätsklinikum Augsburg

    Augsburg, 86156, Germany

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067, United States

  • Vestre Viken HF, Drammen Sykehus

    Drammen, N-3004, Norway

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510, Japan

  • West China Hospital, Sichuan University

    Chengdu, 610042, China

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.