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
- Conditions
- Lung Cancer, Non-squamous, Non-small Cell
- Interventions
- Registration Number
- NCT06151574
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 270
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator arm carboplatin pembrolizumab plus platinum-pemetrexed chemotherapy Comparator arm pembrolizumab pembrolizumab plus platinum-pemetrexed chemotherapy Comparator arm cisplatin pembrolizumab plus platinum-pemetrexed chemotherapy Comparator arm pemetrexed pembrolizumab plus platinum-pemetrexed chemotherapy Experimental treatment arm zongertinib zongertinib only
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 determined by blinded central independent review up to 4 years and 5 months PFS is defined as the time from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.
- Secondary Outcome Measures
Name Time Method Key secondary endpoint: Overall Response (OR) according to RECIST 1.1 determined by blinded central independent review up to 53 months OR is defined as 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.
Key secondary endpoint: Change from baseline to Week 25 of Non-small cell lung cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score at baseline, at week 25 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.Key secondary endpoint: Overall Survival (OS) up to 53 months OS is defined as the time from randomization until death from any cause.
Duration of response (DoR), determined by blinded central independent review up to 53 months 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.
PFS determined by blinded central independent review up to 53 months PFS is defined as the time from randomization until tumor progression or death from any cause, whichever occurs earlier.
Bi-compartmental PFS, determined by blinded central independent review up to 53 months 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.
OR determined by blinded central independent review up to 53 months OR is defined as 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.
Change from baseline to Week 25 in the NSCLC-SAQ pain domain score at baseline, at week 25 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.
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 at baseline, at week 25 The EORTC QLQ-C30 is a quality of life questionnaire. It ranges from 0 to 100, higher scores equal worse outcome.
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
Trial Locations
- Locations (167)
HOP Civil
🇫🇷Strasbourg, France
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Mohtaseb Cancer Center and Blood Disorders, LLC
🇺🇸Bullhead City, Arizona, United States
Precision NextGen Oncology
🇺🇸Beverly Hills, California, United States
ClinRé 001-022 (Premier Cancer Care and Infusion Center)
🇺🇸Fresno, California, United States
OPN Healthcare, Inc.
🇺🇸Glendale, California, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
St. Louis Cancer Care, LLP
🇺🇸Bridgeton, Missouri, United States
Oncology Hematology Associates
🇺🇸Springfield, Missouri, United States
Cancer Care Specialists
🇺🇸Reno, Nevada, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Northwell Health
🇺🇸Lake Success, New York, United States
Regional Medical Oncology Center
🇺🇸Wilson, North Carolina, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Carolina Blood and Cancer Care Associates, PA
🇺🇸Rock Hill, South Carolina, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
INS Curie
🇫🇷Paris, France
Clinica Adventista Belgano
🇦🇷Caba, Argentina
Instituto Medico Especializado Alexander Fleming
🇦🇷Ciudad Autónoma de Bs As, Argentina
Instituto Oncologico de Cordoba
🇦🇷Córdoba, Argentina
Centro Oncologico Riojano Integral (CORI)
🇦🇷La Rioja, Argentina
Instituto Médico de la Fundación Estudios Clínicos
🇦🇷Rosario, Argentina
Clinicas Viedma S.A.
🇦🇷Viedma, Argentina
Prince of Wales Hospital-Randwick-66496
🇦🇺Randwick, New South Wales, Australia
Royal North Shore Hospital-St Leonards-20807
🇦🇺St Leonards, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
St John of God Subiaco Hospital
🇦🇺Subiaco, Western Australia, Australia
Krems University Hospital
🇦🇹Krems an der Donau, Austria
Clinic Floridsdorf
🇦🇹Vienna, Austria
Brussels - HOSP Jules Bordet
🇧🇪Anderlecht, Belgium
UNIV UZ Gent
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Associacao Dr. Bartholomeu Tacchini
🇧🇷Bento Goncalves, Brazil
Hospital do Cancer de Londrina
🇧🇷Londrina, Brazil
Hospital Sao Lucas da PUCRS
🇧🇷Porto Alegre, Brazil
OncoClinicas Rio de Janeiro
🇧🇷Rio de Janeiro, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
🇧🇷Santo André, Brazil
HOP Pontchaillou
🇫🇷Rennes, France
ICESP - Instituto do Cancer do Estado de Sao Paulo
🇧🇷Sao Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José do Rio Preto, Brazil
Bradford Hill- Centro de Investigación Clínica
🇨🇱Recoleta, Chile
Cancer Hospital of Chinese Academy of Medical Science
🇨🇳Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, China
West China Hospital
🇨🇳Chengdu, China
Fujian Cancer Hospital
🇨🇳Fuzhou, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
🇨🇳Hangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Zhongshan Hospital Affiliated to Fudan University
🇨🇳Shanghai, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Wenzhou Med College
🇨🇳Wenzhou, China
Wuhan Union Hospital
🇨🇳Wuhan, China
First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
HOP Louis Pradel
🇫🇷Bron, France
CTR Leon Berard
🇫🇷Lyon, France
HOP Nord
🇫🇷Marseille, France
HOP Tenon
🇫🇷Paris, France
INS Claudius Regaud IUCT-Oncopole
🇫🇷Toulouse, France
INS Gustave Roussy
🇫🇷Villejuif, France
Universitätsklinikum Augsburg
🇩🇪Augsburg, Germany
Gemeinschaftskrankenhaus Havelhöhe gGmbH
🇩🇪Berlin, Germany
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Justus-Liebig Universität Gießen
🇩🇪Gießen, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Köln (AöR)
🇩🇪Köln, Germany
Pius-Hospital, Oldenburg
🇩🇪Oldenburg, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Queen Elizabeth Hospital-Hong Kong-51727
🇭🇰Hong Kong, Hong Kong
Princess Margaret Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Koranyi National Institute For Pulmonolgy
🇭🇺Budapest, Hungary
National Institute of Oncology
🇭🇺Budapest, Hungary
Deszk Hospital of Chest Diseases
🇭🇺Deszk, Hungary
Pulmonology Institute of Veszprem County, Farkasgyepu
🇭🇺Farkasgyepu, Hungary
Fejer County Saint George University Teaching Hospital
🇭🇺Szekesfehervar, Hungary
Rambam Medical Center
🇮🇱Haifa, Israel
Meir Medical Center
🇮🇱Kfar-Saba, Israel
Rabin Medical Center Beilinson
🇮🇱Petach Tikva, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
Istituto Di Candiolo
🇮🇹Candiolo (TO), Italy
AOU Policlinico G. Rodolico San Marco
🇮🇹Catania, Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
🇮🇹Napoli, Italy
Azienda Ospedaliera Unversitaria di Parma
🇮🇹Parma, Italy
AOU Policlinico Umberto I
🇮🇹Roma, Italy
A. O. Ospedale Circolo Fond. Macchi
🇮🇹Varese, Italy
Aichi Cancer Center Hospital
🇯🇵Aichi, Nagoya, Japan
Hirosaki University Hospital
🇯🇵Aomori, Hirosaki, Japan
National Cancer Center Hospital East
🇯🇵Chiba, Kashiwa, Japan
Shikoku Cancer Center
🇯🇵Ehime, Matsuyama, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Fukuoka, Japan
Hakodate Goryoukaku Hospital
🇯🇵Hokkaido, Hakodate, Japan
Hokkaido Cancer Center
🇯🇵Hokkaido, Sapporo, Japan
Kanazawa University Hospital
🇯🇵Ishikawa, Kanazawa, Japan
St. Marianna University Hospital
🇯🇵Kanagawa, Kawasaki, Japan
Kanagawa Cancer Center
🇯🇵Kanagawa, Yokohama, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Kyoto, Japan
Tohoku University Hospital
🇯🇵Miyagi, Sendai, Japan
Okayama University Hospital
🇯🇵Okayama, Okayama, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Osaka, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Sunto-gun, Japan
Juntendo University Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Komagome Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
Japanese Foundation for Cancer Research
🇯🇵Tokyo, Koto-ku, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Wakayama, Japan
Chungbuk National University Hospital
🇰🇷Cheongiu, Korea, Republic of
National Cancer Center
🇰🇷Goyang, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St.Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Health Pharma Professional Research S.A. de C.V.
🇲🇽Ciudad de Mexico, Mexico
Centro Oncologico Personalizado
🇲🇽Mexico, Mexico
Instituto Nacional de Cancerologia
🇲🇽Mexico, Mexico
FAICIC S de RL de C.V.
🇲🇽Veracruz, Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
🇳🇱Amsterdam, Netherlands
Maastricht University
🇳🇱Maastricht, Netherlands
Vestre Viken HF, Drammen Sykehus
🇳🇴Drammen, Norway
Oslo Universitetssykehus HF, Radiumhospitalet
🇳🇴Oslo, Norway
Polish Mother's Memorial Hospital - Research Institute
🇵🇱Lodz, Poland
Greater Poland Center of Pulmonology and Thoracic Surgery
🇵🇱Poznan, Poland
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
🇵🇱Poznan, Poland
Oncology Center-Maria Sklodowska-Curie Institute
🇵🇱Warsaw, Poland
Hospital CUF Tejo
🇵🇹Lisboa, Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
🇵🇹Lisboa, Portugal
Hospital CUF Porto
🇵🇹Porto, Portugal
Pan American Center for Oncology Trials, LLC
🇵🇷Rio Piedras, Puerto Rico
National University Hospital-Singapore-22806
🇸🇬Singapore, Singapore
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Hospital A Coruña
🇪🇸A Coruña, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Sahlgrenska Universitetsjukhuset
🇸🇪Göteborg, Sweden
Karolinska Universitetssjukhuset Solna
🇸🇪Stockholm, Sweden
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Cancer Center
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital(Linkou)
🇨🇳Taoyuan, Taiwan
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom
The Royal Marsden Hospital, Chelsea
🇬🇧London, United Kingdom
The Royal Marsden Hospital, Sutton
🇬🇧Sutton, United Kingdom