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

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. 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer, Non-squamous, Non-small Cell
• Intervention / Treatment: Drug: pembrolizumab; Drug: zongertinib; Drug: cisplatin; Drug: carboplatin; Drug: pemetrexed

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, 1430
    • Clinica Adventista Belgrano
  • Ciudad Autónoma de Bs As, Argentina, C1426ANZ
    • Instituto Médico Especializado Alexander Fleming
  • Córdoba, Argentina, X5000
    • Instituto Oncologico de Cordoba
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (Cori)
  • Rosario, Argentina, S2000DEJ
    • Instituto Médico de la Fundación Estudios Clínicos
• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital-Randwick-66496
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital-St Leonards-20807
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • St John of God Subiaco Hospital
• Austria
  • Krems, Austria, 3500
    • Krems University Hospital
  • Vienna, Austria, 1210
    • Clinic Floridsdorf
• Belgium
  • Anderlecht, Belgium, 1070
    • Brussels - HOSP Jules Bordet
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
• Brazil
  • Bento Gonçalves, Brazil, 95700-084
    • Associacao Dr. Bartholomeu Tacchini
  • Londrina, Brazil, 86015-520
    • Hospital do Cancer de Londrina
  • Porto Alegre, Brazil, 90610-000
    • Hospital Sao Lucas da PUCRS
  • Rio de Janeiro, Brazil, 22250-040
    • Oncoclinicas Rio de Janeiro
  • Santo André, Brazil, 09060-650
    • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
  • São José do Rio Preto, Brazil, 15090-000
    • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • São Paulo, Brazil, 01246-000
    • Icesp - Instituto Do Câncer Do Estado de São Paulo
• Chile
  • Recoleta, Chile, 8420383
    • Bradford Hill- Centro de Investigación Clínica
• China
  • Beijing, China, 100142
    • Beijing Cancer hospital
  • Beijing, China, 1000021
    • Cancer Hospital of Chinese Academy of Medical Science
  • Chengdu, China, 610042
    • West China Hospital, Sichuan University
  • Fuzhou, China, 350014
    • Fujian Cancer Hospital
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310003
    • The First Affiliated Hospital, Zhejiang University
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 200032
    • Zhongshan Hospital Affiliated to Fudan University
  • Taizhou, China, 317099
    • Taizhou Hospital of Zhejiang Province
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430022
    • Wuhan Union Hospital
  • Xiamen, China, 361003
    • First Affiliated Hospital of Xiamen University
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• France
  • Bron, France, 69677
    • Hôpital Louis Pradel
  • Lyon, France, 69373
    • CTR Leon Berard
  • Marseille, France, 13015
    • HOP Nord
  • Paris, France, 75248
    • INS Curie
  • Paris, France, 75020
    • HOP Tenon
  • Rennes, France, 35000
    • HOP Pontchaillou
  • Strasbourg, France, 67091
    • HOP Civil
  • Toulouse, France, 31059
    • Hôpital Larrey - CHU de Toulouse
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Augsburg, Germany, 86156
    • Universitätsklinikum Augsburg
  • Berlin, Germany, 14089
    • Gemeinschaftskrankenhaus Havelhöhe gGmbH
  • Cologne, Germany, 50937
    • Universitätsklinikum Köln (AöR)
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Giessen, Germany, 35392
    • Justus-Liebig Universität Gießen
  • Heidelberg, Germany, 69126
    • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
  • Oldenburg, Germany, 26121
    • Pius-Hospital, Oldenburg
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Queen Mary Hospital
  • Hong Kong, Hong Kong, 999077
    • Princess Margaret Hospital
  • Hong Kong, Hong Kong, 51727
    • Queen Elizabeth Hospital-Hong Kong-51727
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center Beilinson
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center
• Italy
  • Bari, Italy, 70124
    • Istituto Tumori Giovanni Paolo II
  • Candiolo (TO), Italy, 10060
    • Istituto Di Candiolo
  • Catania, Italy, 95123
    • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
  • Naples, Italy, 80131
    • Istituto Nazionale IRCCS Tumori Fondazione Pascale
  • Parma, Italy, 43100
    • Azienda Ospedaliera Unversitaria di Parma
  • Roma, Italy, 00161
    • AOU Policlinico Umberto I
  • Varese, Italy, 21100
    • A. O. Ospedale Circolo Fond. Macchi
• Japan
  • Aichi, Nagoya, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Aomori, Hirosaki, Japan, 036-8563
    • Hirosaki University Hospital
  • Chiba, Kashiwa, Japan, 277-8577
    • National Cancer Center Hospital East
  • Ehime, Matsuyama, Japan, 791-0280
    • Shikoku Cancer Center
  • Fukuoka, Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Hokkaido, Hakodate, Japan, 040-8611
    • Hakodate Goryoukaku Hospital
  • Hokkaido, Sapporo, Japan, 003-0804
    • Hokkaido Cancer Center
  • Ishikawa, Kanazawa, Japan, 920-8641
    • Kanazawa University Hospital
  • Kanagawa, Kawasaki, Japan, 216-8511
    • St. Marianna University Hospital
  • Kanagawa, Yokohama, Japan, 241-8515
    • Kanagawa cancer center
  • Kyoto, Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Miyagi, Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Okayama, Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Shizuoka, Sunto-gun, Japan, 411-8777
    • Shizuoka Cancer Center
  • Tokyo, Bunkyo-ku, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Bunkyo-ku, Japan, 113-8677
    • Komagome Hospital
  • Tokyo, Chuo-ku, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Koto-ku, Japan, 135-8550
    • Japanese Foundation for Cancer Research
  • Wakayama, Wakayama, Japan, 641-8510
    • Wakayama Medical University Hospital
• Mexico
  • Mexico City, Mexico, 03100
    • Health Pharma Professional Research S.A. de C.V.
  • México, Mexico, 14080
    • Instituto Nacional De Cancerologia
  • México, Mexico, 06760
    • Centro Oncologico Personalizado
  • Veracruz, Mexico, 91900
    • FAICIC S de RL de C.V.
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medisch Centrum
• Norway
  • Drammen, Norway, N-3004
    • Vestre Viken HF, Drammen Sykehus
  • Oslo, Norway, 0379
    • Oslo Universitetssykehus HF, Radiumhospitalet
• Poland
  • Lodz, Poland, 93-338
    • Polish Mother's Memorial Hospital - Research Institute
  • Poznan, Poland, 60-569
    • Greater Poland Center of Pulmonology and Thoracic Surgery
  • Poznan, Poland, 60693
    • MED POLONIA SP Z O O, Clinical Trials Department,Poznan
  • Warsaw, Poland, 02-781
    • Oncology Center-Maria Sklodowska-Curie Institute
• Portugal
  • Lisbon, Portugal, 1350-352
    • Hospital Cuf Tejo
  • Lisbon, Portugal, 1769-001
    • Centro Hospitalar Lisboa Norte Hospital Pulido Valente
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC
• Singapore
  • Singapore, Singapore, 168583
    • National Cancer Centre Singapore
  • Singapore, Singapore, 119228
    • National University Hospital-Singapore-22806
• South Korea
  • Cheongiu, South Korea, 28644
    • Chungbuk National University Hospital
  • Goyang, South Korea, 10408
    • National Cancer Center
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Suwon, South Korea, 16247
    • The Catholic University of Korea, St.Vincent's Hospital
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruna
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08026
    • Hospital Santa Creu i Sant Pau
  • Barcelona, Spain, 08908
    • Hospital Duran i Reynals
  • Bilbao, Spain, 48013
    • Hospital de Basurto
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Marañon
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Málaga
  • Seville, Spain, 41013
    • Hospital Virgen Del Rocio
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska Universitetsjukhuset
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset Solna
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 404
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 106
    • National Taiwan University Cancer Center
  • Taoyuan, Taiwan, 330
    • Chang Gung Memorial Hospital, Linkou
• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden Hospital, Chelsea
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden Hospital, Sutton
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Clearview Cancer Institute
  • Arizona
    • Bullhead City, Arizona, United States, 86442
      • Pioneer Research Center - Bullhead City
  • California
    • Beverly Hills, California, United States, 90212
      • Precision NextGen Oncology
    • Fresno, California, United States, 93710
      • ClinRé 001-022 (Premier Cancer Care and Infusion Center)
    • Glendale, California, United States, 91203
      • OPN Healthcare, Inc.
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • St. Louis Cancer Care, LLP
    • Springfield, Missouri, United States, 65807
      • Oncology Hematology Associates
  • Nevada
    • Reno, Nevada, United States, 89511
      • Cancer Care Specialists
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Wilson, North Carolina, United States, 27893
      • Regional Medical Oncology Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Blood and Cancer Care Associates, PA
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • SCRI Oncology Partners
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • Washington
    • Edmonds, Washington, United States, 98026
      • Swedish Cancer Institute
    • Issaquah, Washington, United States, 98029
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental treatment arm; zongertinib only	Drug: zongertinib; zongertinib; Other Names: BI 1810631, Hernexeos®
Active Comparator: Comparator arm; pembrolizumab plus platinum-pemetrexed chemotherapy	Drug: pembrolizumab; pembrolizumab; Other Names: Keytruda®; Drug: cisplatin; platinum-pemetrexed chemotherapy; Drug: carboplatin; platinum-pemetrexed chemotherapy; Drug: pemetrexed; platinum-pemetrexed chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 4 years and 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at baseline, at week 25
Key secondary endpoint: Overall Survival (OS)	OS is defined as the time from randomization until death from any cause.	up to 53 months
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.	up to 53 months
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.	up to 53 months
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.	up to 53 months
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.	at baseline, at week 25
Change from baseline to Week 25 in the NSCLC-SAQ dyspnea domain score		at baseline, at week 25
Change from baseline to Week 25 in the NSCLC-SAQ cough domain score		at baseline, at week 25
Change from baseline to Week 25 in the NSCLC-SAQ appetite domain score		at baseline, at week 25
Change from baseline to Week 25 in the NSCLC-SAQ fatigue domain score		at baseline, at week 25
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.	at baseline, at week 25
Occurrence of adverse events (AEs) during the on-treatment period, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0		up to 53 months
Occurrence of serious AEs (SAEs) during the on-treatment period, graded according to CTCAE version 5.0		up to 53 months
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.	up to 53 months
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.	up to 53 months

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): January 28, 2028

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Platinum Compounds; Pemetrexed; Carboplatin; Cisplatin; pembrolizumab
• Other Study ID Numbers: 1479-0008; 2023-504308-27-00 (Registry Identifier: CTIS); U1111-1294-1407 (Other Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No