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Lung Cancer, Non-squamous, Non-small CellPhase 3NCT06151574

Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

A Phase 3 study testing zongertinib, pembrolizumab and cisplatin in people with Lung Cancer, Non-squamous, Non-small Cell, run by Boehringer Ingelheim at 163 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
zongertinib, pembrolizumab and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
428 participants
Where
163 sitesin 26 countries
Study dates
9 Feb 2024to 28 Jan 2028
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

  • 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.
  • 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.
  • Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous Non-small cell lung cancer (NSCLC).
  • Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results.
  • 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.
  • Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy.
Show all 9Show fewer
  • 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.
  • 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.

Who cannot join

  • 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
  • Tumors with targetable alterations with approved available therapy.
Show all 13Show fewer
  • Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

163 sites in 26 countries.

163 sites in 26 countries

United States22 sites

  • Precision NextGen Oncology

    Beverly Hills, California, 90212

  • St. Louis Cancer Care, LLP

    Bridgeton, Missouri, 63044

  • Pioneer Research Center - Bullhead City

    Bullhead City, Arizona, 86442

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Swedish Cancer Institute

    Edmonds, Washington, 98026

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

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

    Fresno, California, 93710

  • OPN Healthcare, Inc.

    Glendale, California, 91203

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Swedish Cancer Institute

    Issaquah, Washington, 98029

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Northwell Health

    Lake Success, New York, 11042

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Cancer Care Specialists

    Reno, Nevada, 89511

  • Carolina Blood and Cancer Care Associates, PA

    Rock Hill, South Carolina, 29732

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Regional Medical Oncology Center

    Wilson, North Carolina, 27893

Other trials in United States

Japan20 sites

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681

  • Hirosaki University Hospital

    Aomori, Hirosaki, 036-8563

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • Shikoku Cancer Center

    Ehime, Matsuyama, 791-0280

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Hakodate Goryoukaku Hospital

    Hokkaido, Hakodate, 040-8611

  • Hokkaido Cancer Center

    Hokkaido, Sapporo, 003-0804

  • Kanazawa University Hospital

    Ishikawa, Kanazawa, 920-8641

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511

  • Kanagawa Cancer Center

    Kanagawa, Yokohama, 241-8515

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Okayama University Hospital

    Okayama, Okayama, 700-8558

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Shizuoka Cancer Center

    Shizuoka, Sunto-gun, 411-8777

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 113-8431

  • Komagome Hospital

    Tokyo, Bunkyo-ku, 113-8677

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

Other trials in Japan

China16 sites

  • Cancer Hospital of Chinese Academy of Medical Science

    Beijing, 1000021

  • Beijing Cancer Hospital

    Beijing, 100142

  • West China Hospital, Sichuan University

    Chengdu, 610042

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, 310003

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

    Hangzhou, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, 200032

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317099

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

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

    Wuhan, 430022

  • First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Spain13 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

France9 sites

  • Hopital Louis Pradel

    Bron, 69677

  • CTR Leon Berard

    Lyon, 69373

  • HOP Nord

    Marseille, 13015

  • HOP Tenon

    Paris, 75020

  • INS Curie

    Paris, 75248

  • HOP Pontchaillou

    Rennes, 35000

  • HOP Civil

    Strasbourg, 67091

  • Hôpital Larrey - CHU de Toulouse

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany8 sites

  • Universitätsklinikum Augsburg

    Augsburg, 86156

  • Gemeinschaftskrankenhaus Havelhöhe gGmbH

    Berlin, 14089

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Justus-Liebig Universität Gießen

    Giessen, 35392

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Pius-Hospital, Oldenburg

    Oldenburg, 26121

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

South Korea8 sites

  • Chungbuk National University Hospital

    Cheongiu, 28644

  • National Cancer Center

    Goyang, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

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

    Suwon, 16247

Other trials in South Korea

Brazil7 sites

  • Associacao Dr. Bartholomeu Tacchini

    Bento Gonçalves, 95700-084

  • Hospital do Câncer de Londrina

    Londrina, 86015-520

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • OncoClinicas Rio de Janeiro

    Rio de Janeiro, 22250-905

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

    Santo André, 09060-650

  • Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000

  • ICESP - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246-000

Other trials in Brazil

Italy7 sites

  • Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • Istituto Di Candiolo

    Candiolo (TO), 10060

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

    Catania, 95123

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    Naples, 80131

  • Azienda Ospedaliera Unversitaria di Parma

    Parma, 43100

  • AOU Policlinico Umberto I

    Roma, 00161

  • A. O. Ospedale Circolo Fond. Macchi

    Varese, 21100

Other trials in Italy

Argentina5 sites

  • Clinica Adventista Belgrano

    CABA, 1430

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autónoma de Bs As, C1426ANZ

  • Instituto Oncologico de Cordoba

    Córdoba, X5000

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2000DEJ

Other trials in Argentina

Australia5 sites

  • Austin Health

    Heidelberg, Victoria, 3084

  • Prince of Wales Hospital-Randwick-66496

    Randwick, New South Wales, 2031

  • Royal North Shore Hospital-St Leonards-20807

    St Leonards, New South Wales, 2065

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Taiwan5 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Chung Shan Medical University Hospital

    Taichung, 404

  • National Taiwan University Hospital

    Taipei, 100

  • National Taiwan University Cancer Center

    Taipei, 106

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 330

Other trials in Taiwan

United Kingdom5 sites

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Guy's Hospital

    London, SE1 9RT

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ

  • The Royal Marsden Hospital, Sutton

    Sutton, SM2 5PT

Other trials in United Kingdom

Israel4 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100

  • Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Mexico4 sites

  • Centro Oncologico Personalizado

    México, 06760

  • Instituto Nacional de Cancerologia

    México, 14080

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

    Mexico City, 03100

  • FAICIC S de RL de C.V.

    Veracruz, 91900

Other trials in Mexico

Poland4 sites

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz, 93-338

  • Greater Poland Center of Pulmonology and Thoracic Surgery

    Poznan, 60-569

  • Med Polonia Sp. z o.o

    Poznan, 60693

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw, 02-781

Other trials in Poland

Belgium3 sites

  • Brussels - HOSP Jules Bordet

    Anderlecht, 1070

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Hong Kong3 sites

  • Queen Elizabeth Hospital-Hong Kong-51727

    Hong Kong, 51727

  • Princess Margaret Hospital

    Hong Kong, 999077

  • Queen Mary Hospital

    Hong Kong, 999077

Other trials in Hong Kong

Portugal3 sites

  • Hospital CUF Tejo

    Lisbon, 1350-352

  • Centro Hospitalar Lisboa Norte Hospital Pulido Valente

    Lisbon, 1769-001

  • Hospital CUF Porto

    Porto, 4100-180

Other trials in Portugal

Austria2 sites

  • Krems University Hospital

    Krems, 3500

  • Clinic Floridsdorf

    Vienna, 1210

Other trials in Austria

Netherlands2 sites

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

    Amsterdam, 1066 CX

  • Maastricht University Medisch Centrum

    Maastricht, 6229 HX

Other trials in Netherlands

Norway2 sites

  • Vestre Viken HF, Drammen Sykehus

    Drammen, N-3004

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, 0379

Other trials in Norway

Singapore2 sites

  • National University Hospital-Singapore-22806

    Singapore, 119228

  • National Cancer Centre Singapore

    Singapore, 168583

Other trials in Singapore

Sweden2 sites

  • Sahlgrenska Universitetsjukhuset

    Gothenburg, 413 45

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76

Other trials in Sweden

Chile1 site

  • Bradford Hill- Centro de Investigacion Clinica

    Recoleta, 8420383

Other trials in Chile

Puerto Rico1 site

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations

This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy.

Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein.

Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. Some visits may be conducted remotely later in the study if approved by the study doctor. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.

Being tested
zongertinib, pembrolizumab, cisplatin, carboplatin, pemetrexed
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zongertinibDrug

    Also called BI 1810631, Hernexeos®

    zongertinib

  • pembrolizumabDrug

    Also called Keytruda®

    pembrolizumab

  • cisplatinDrug

    platinum-pemetrexed chemotherapy

  • carboplatinDrug

    platinum-pemetrexed chemotherapy

  • pemetrexedDrug

    platinum-pemetrexed chemotherapy

Study groups in NCT06151574
Study groupRoleWhat they receive
Experimental treatment armExperimentalzongertinib only
Receives: Drug: zongertinib
Comparator armActive comparatorpembrolizumab plus platinum-pemetrexed chemotherapy
Receives: Drug: pembrolizumab; Drug: cisplatin; Drug: carboplatin; Drug: pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 determined by blinded central independent review

    PFS is defined as the time from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.

    Measured: up to 4 years and 5 months

Secondary outcomes (15)

  1. Key secondary endpoint: Overall Response (OR) according to RECIST 1.1 determined by blinded central independent review

    OR is defined as confirmed best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to RECIST 1.1 from date of randomization until the earliest of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent.

    Measured: up to 53 months

  2. Key secondary endpoint: Change from baseline to Week 25 of Non-small cell lung cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score

    The NSCLC-SAQ is a 7-item patient-reported outcome measure for use in adults to assess symptoms of advanced NSCLC.

    It contains five domains and accompanying items that were identified as symptoms of NSCLC: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1).

    The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms.

    Measured: at baseline, at week 25

  3. Key secondary endpoint: Overall Survival (OS)

    OS is defined as the time from randomization until death from any cause.

    Measured: up to 53 months

  4. Duration of response (DoR), determined by blinded central independent review

    DoR is defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response.

    Measured: up to 53 months

  5. PFS determined by blinded central independent review

    PFS is defined as the time from randomization until tumor progression or death from any cause, whichever occurs earlier.

    Measured: up to 53 months

  6. Bi-compartmental PFS, determined by blinded central independent review

    Bi-compartmental PFS is defined as the time from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.

    Measured: up to 53 months

  7. OR determined by blinded central independent review

    OR is defined as confirmed best overall response of CR or PR, from date of randomization until the earliest progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent.

    Measured: up to 53 months

  8. Change from baseline to Week 25 in the NSCLC-SAQ pain domain score

    The individual NSCLC-SAQ items use a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to an (item) score of 0 to 4. A higher score indicates more severe symptoms.

    Measured: at baseline, at week 25

  9. Change from baseline to Week 25 in the NSCLC-SAQ dyspnea domain score

    Measured: at baseline, at week 25

  10. Change from baseline to Week 25 in the NSCLC-SAQ cough domain score

    Measured: at baseline, at week 25

  11. Change from baseline to Week 25 in the NSCLC-SAQ appetite domain score

    Measured: at baseline, at week 25

  12. Change from baseline to Week 25 in the NSCLC-SAQ fatigue domain score

    Measured: at baseline, at week 25

  13. Change from baseline to Week 25 in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) physical functioning domain score

    The EORTC QLQ-C30 is a quality of life questionnaire. It ranges from 0 to 100, higher scores equal worse outcome.

    Measured: at baseline, at week 25

  14. Occurrence of adverse events (AEs) during the on-treatment period, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: up to 53 months

  15. Occurrence of serious AEs (SAEs) during the on-treatment period, graded according to CTCAE version 5.0

    Measured: up to 53 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2023
  2. Study start9 Feb 2024
  3. Primary completion10 Dec 2026 (estimated)
  4. Study completion28 Jan 2028 (estimated)

Resources

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
None (open label)
Enrolment
428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06151574
Sponsor's protocol ID
1479-0008
Other IDs
2023-504308-27-00, U1111-1294-1407, 2023
Status last verified
Sep 2026
First submitted
22 Nov 2023
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Publications

  • Puri S, Ismaila N, Azar IH, Freeman-Daily J, Furuya N, Kuruvilla S, Roof L, Velazquez AI, Wang Y, Wheatley Price P, Leighl NB. Therapy for Stage IV Non-Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2026.3.2. J Clin Oncol. 2026 Sep 10;44(26):e127-e139. doi: 10.1200/JCO-26-01479. Epub 2026 Jun 29.

    PubMed 42372216

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing zongertinib, pembrolizumab and cisplatin in people with Lung Cancer, Non-squamous, Non-small Cell, run by Boehringer Ingelheim at 163 sites in 26 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 9 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 1 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 163 sites in United States, Japan, China, Spain, France and 21 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 determined by blinded central independent review (time frame: up to 4 years and 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06151574, which also lists 1 linked publication.

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 1 Oct 2026.

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