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

Status: Recruiting
Location: See all (169) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
Alabama
Clearview Cancer Institute
NOT_YET_RECRUITING
Huntsville
Arizona
Mohtaseb Cancer Center and Blood Disorders, LLC
NOT_YET_RECRUITING
Bullhead City
California
Precision NextGen Oncology
NOT_YET_RECRUITING
Beverly Hills
ClinRé 001-022 (Premier Cancer Care and Infusion Center)
NOT_YET_RECRUITING
Fresno
OPN Healthcare, Inc.
NOT_YET_RECRUITING
Glendale
Scripps Green Hospital
RECRUITING
La Jolla
Valkyrie Clinical Trials
RECRUITING
Los Angeles
Sharp Memorial Hospital
RECRUITING
San Diego
Missouri
St. Louis Cancer Care, LLP
NOT_YET_RECRUITING
Bridgeton
Oncology Hematology Associates
NOT_YET_RECRUITING
Springfield
North Carolina
Regional Medical Oncology Center
NOT_YET_RECRUITING
Wilson
Nevada
Cancer Care Specialists
RECRUITING
Reno
New York
Northwell Health
NOT_YET_RECRUITING
Lake Success
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Gabrail Cancer Center
NOT_YET_RECRUITING
Canton
South Carolina
Carolina Blood and Cancer Care Associates, PA
COMPLETED
Rock Hill
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Washington
Swedish Cancer Institute
NOT_YET_RECRUITING
Edmonds
Swedish Cancer Institute
NOT_YET_RECRUITING
Issaquah
Swedish Cancer Institute
RECRUITING
Seattle
Other Locations
Argentina
Clinica Adventista Belgrano
NOT_YET_RECRUITING
Caba
Instituto Medico Especializado Alexander Fleming
NOT_YET_RECRUITING
Ciudad Autónoma De Bs As
Instituto Oncologico de Cordoba
NOT_YET_RECRUITING
Córdoba
Centro Oncologico Riojano Integral (CORI)
NOT_YET_RECRUITING
La Rioja
Instituto Médico de la Fundación Estudios Clínicos
NOT_YET_RECRUITING
Rosario
Clinicas Viedma S.A.
NOT_YET_RECRUITING
Viedma
Australia
Austin Health
RECRUITING
Heidelberg
Prince of Wales Hospital-Randwick-66496
RECRUITING
Randwick
Royal North Shore Hospital-St Leonards-20807
RECRUITING
St Leonards
St John of God Subiaco Hospital
RECRUITING
Subiaco
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Krems University Hospital
RECRUITING
Krems
Clinic Floridsdorf
RECRUITING
Vienna
Belgium
Brussels - HOSP Jules Bordet
RECRUITING
Anderlecht
UNIV UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Brazil
Associacao Dr. Bartholomeu Tacchini
NOT_YET_RECRUITING
Bento Gonçalves
Hospital do Cancer de Londrina
NOT_YET_RECRUITING
Londrina
Hospital Sao Lucas da PUCRS
RECRUITING
Porto Alegre
OncoClinicas Rio de Janeiro
RECRUITING
Rio De Janeiro
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
NOT_YET_RECRUITING
Santo André
Fundação Faculdade Regional de Medicina de São José do Rio Preto
NOT_YET_RECRUITING
São José Do Rio Preto
ICESP - Instituto do Cancer do Estado de Sao Paulo
RECRUITING
São Paulo
Canada
Princess Margaret Cancer Centre
NOT_YET_RECRUITING
Toronto
Chile
Bradford Hill- Centro de Investigación Clínica
RECRUITING
Recoleta
China
Beijing Cancer Hospital
RECRUITING
Beijing
Cancer Hospital of Chinese Academy of Medical Science
NOT_YET_RECRUITING
Beijing
West China Hospital of Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Zhongshan Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Taizhou Hospital of Zhejiang Province
RECRUITING
Taizhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Wuhan Union Hospital
RECRUITING
Wuhan
First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Henan Cancer Hospital
RECRUITING
Zhengzhou
France
HOP Louis Pradel
NOT_YET_RECRUITING
Bron
CTR Leon Berard
RECRUITING
Lyon
HOP Nord
RECRUITING
Marseille
HOP Tenon
RECRUITING
Paris
INS Curie
RECRUITING
Paris
HOP Pontchaillou
RECRUITING
Rennes
HOP Civil
RECRUITING
Strasbourg
HOP Larrey
RECRUITING
Toulouse
INS Gustave Roussy
RECRUITING
Villejuif
Germany
Universitätsklinikum Augsburg
RECRUITING
Augsburg
Gemeinschaftskrankenhaus Havelhöhe gGmbH
RECRUITING
Berlin
Universitätsklinikum Köln (AöR)
RECRUITING
Cologne
Universitätsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Justus-Liebig Universität Gießen
NOT_YET_RECRUITING
Giessen
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Pius-Hospital, Oldenburg
RECRUITING
Oldenburg
Universitätsklinikum Tübingen
NOT_YET_RECRUITING
Tübingen
Hong Kong Special Administrative Region
Princess Margaret Hospital
RECRUITING
Hong Kong
Queen Elizabeth Hospital-Hong Kong-51727
RECRUITING
Hong Kong
Queen Mary Hospital
NOT_YET_RECRUITING
Hong Kong
Hungary
Koranyi National Institute For Pulmonolgy
NOT_YET_RECRUITING
Budapest
National Institute of Oncology
NOT_YET_RECRUITING
Budapest
Deszk Hospital of Chest Diseases
NOT_YET_RECRUITING
Deszk
Pulmonology Institute of Veszprem County, Farkasgyepu
NOT_YET_RECRUITING
Farkasgyepű
Fejer County Saint George University Teaching Hospital
NOT_YET_RECRUITING
Székesfehérvár
Israel
Rambam Medical Center
RECRUITING
Haifa
Meir Medical Center
RECRUITING
Kfar Saba
Rabin Medical Center Beilinson
RECRUITING
Petah Tikva
Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Istituto Tumori Giovanni Paolo II
RECRUITING
Bari
Istituto Di Candiolo
NOT_YET_RECRUITING
Candiolo (to)
AOU Policlinico G. Rodolico San Marco
RECRUITING
Catania
Istituto Nazionale IRCCS Tumori Fondazione Pascale
RECRUITING
Napoli
Azienda Ospedaliera Unversitaria di Parma
RECRUITING
Parma
AOU Policlinico Umberto I
NOT_YET_RECRUITING
Roma
A. O. Ospedale Circolo Fond. Macchi
NOT_YET_RECRUITING
Varese
Japan
Aichi Cancer Center Hospital
RECRUITING
Aichi, Nagoya
Hirosaki University Hospital
RECRUITING
Aomori, Hirosaki
National Cancer Center Hospital East
NOT_YET_RECRUITING
Chiba, Kashiwa
Shikoku Cancer Center
RECRUITING
Ehime, Matsuyama
Kyushu University Hospital
RECRUITING
Fukuoka, Fukuoka
Hakodate Goryoukaku Hospital
RECRUITING
Hokkaido, Hakodate
Hokkaido Cancer Center
RECRUITING
Hokkaido, Sapporo
Kanazawa University Hospital
RECRUITING
Ishikawa, Kanazawa
St. Marianna University Hospital
RECRUITING
Kanagawa, Kawasaki
Kanagawa Cancer Center
RECRUITING
Kanagawa, Yokohama
University Hospital Kyoto Prefectural University of Medicine
RECRUITING
Kyoto, Kyoto
Tohoku University Hospital
RECRUITING
Miyagi, Sendai
Okayama University Hospital
RECRUITING
Okayama, Okayama
Osaka International Cancer Institute
RECRUITING
Osaka, Osaka
Shizuoka Cancer Center
RECRUITING
Shizuoka, Sunto-gun
Juntendo University Hospital
RECRUITING
Tokyo, Bunkyo-ku
Komagome Hospital
RECRUITING
Tokyo, Bunkyo-ku
National Cancer Center Hospital
RECRUITING
Tokyo, Chuo-ku
Japanese Foundation for Cancer Research
RECRUITING
Tokyo, Koto-ku
Wakayama Medical University Hospital
RECRUITING
Wakayama, Wakayama
Mexico
Instituto Nacional de Cancerologia
NOT_YET_RECRUITING
México
Health Pharma Professional Research S.A. de C.V.
RECRUITING
Mexico City
FAICIC S de RL de C.V.
NOT_YET_RECRUITING
Veracruz
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
RECRUITING
Amsterdam
Maastricht University
RECRUITING
Maastricht
Norway
Vestre Viken HF, Drammen Sykehus
NOT_YET_RECRUITING
Drammen
Oslo Universitetssykehus HF, Radiumhospitalet
NOT_YET_RECRUITING
Oslo
Poland
Polish Mother's Memorial Hospital - Research Institute
NOT_YET_RECRUITING
Lodz
Greater Poland Center of Pulmonology and Thoracic Surgery
NOT_YET_RECRUITING
Poznan
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
RECRUITING
Poznan
Oncology Center-Maria Sklodowska-Curie Institute
NOT_YET_RECRUITING
Warsaw
Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
NOT_YET_RECRUITING
Lisbon
Hospital CUF Tejo
NOT_YET_RECRUITING
Lisbon
Hospital CUF Porto
RECRUITING
Porto
Puerto Rico
Pan American Center for Oncology Trials, LLC
NOT_YET_RECRUITING
Rio Piedras
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongiu
National Cancer Center
RECRUITING
Goyang
Gachon University Gil Medical Center
NOT_YET_RECRUITING
Incheon
Asan Medical Center
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
The Catholic University of Korea, St.Vincent's Hospital
RECRUITING
Suwon
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
National University Hospital-Singapore-22806
RECRUITING
Singapore
Spain
Hospital A Coruña
NOT_YET_RECRUITING
A Coruña
Hospital General Universitario de Alicante
NOT_YET_RECRUITING
Alicante
Hospital Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall D Hebron
RECRUITING
Barcelona
Hospital de Basurto
RECRUITING
Bilbao
Hospital Duran i Reynals
RECRUITING
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramon Y Cajal
RECRUITING
Madrid
Hospital Regional Universitario de Málaga
NOT_YET_RECRUITING
Málaga
Hospital Virgen del Rocío
RECRUITING
Seville
Hospital Clínico de Valencia
RECRUITING
Valencia
Sweden
Sahlgrenska Universitetsjukhuset
NOT_YET_RECRUITING
Gothenburg
Karolinska Universitetssjukhuset Solna
RECRUITING
Stockholm
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Chung Shan Medical University Hospital
RECRUITING
Taichung
National Taiwan University Cancer Center
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital Linkou
RECRUITING
Taoyuan District
United Kingdom
Western General Hospital
RECRUITING
Edinburgh
Leicester Royal Infirmary
RECRUITING
Leicester
Guy's Hospital
RECRUITING
London
The Royal Marsden Hospital, Chelsea
RECRUITING
London
The Royal Marsden Hospital, Sutton
RECRUITING
Sutton
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2024-02-09
Estimated Completion Date: 2028-01-28
Participants
Target number of participants: 416
Treatments
Experimental: Experimental treatment arm
zongertinib only
Active_comparator: Comparator arm
pembrolizumab plus platinum-pemetrexed chemotherapy
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

Similar Clinical Trials