Spots Global Cancer Trial Database for A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
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Trial Identification
Brief Title: A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Official Title: A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy
Study ID: NCT05388669
Study Description
Brief Summary: The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Duarte, Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California, United States
City of Hope Long Beach Elm, Long Beach, California, United States
National Jewish Health, Denver, Colorado, United States
Baptist Lynn Cancer Institute, Boca Raton, Florida, United States
Orlando Health, Orlando, Florida, United States
University of Kansas, Kansas City, Kansas, United States
University of Michigan, Ann Arbor, Michigan, United States
Astera Cancer Care, East Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
NYU Langone Health Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic - Westside, Portland, Oregon, United States
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
CEMIC (Centro de Educación Médica e Investigaciones Clínicas), Buenos Aires, , Argentina
IADT Instituto Argentino de Diagnostico y Tratamiento, Caba, , Argentina
Centro Oncológico Korben, Ciudad Autonoma de Buenos Aires, , Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Cordoba, , Argentina
Sanatorio Allende, Cordoba, , Argentina
Clínica Viedma, Viedma, , Argentina
Cancer Research SA, Adelaide, , Australia
Chris O'Brien Lifehouse, Camperdown, , Australia
Peter MacCallum Cancer Centre, Melbourne, , Australia
St John of God Hospital Murdoch, Murdoch, , Australia
Westmead Hospital, Westmead, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
Fundacao Pio XII, Barretos, , Brazil
Cetus Oncologia, Belo Horizonte, , Brazil
Instituto Cionc de Ensino e Pesquisa S/S, Curitiba, , Brazil
Ynova Pesquisa Clinica, Florianopolis, , Brazil
Fundacao Sao Francisco Xavier HMC Unidade de Oncologia, Ipatinga, , Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia, Pelotas, , Brazil
Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS, Porto Alegre, , Brazil
Impar Servicos Hospitalares S/A, Rio de Janeiro, , Brazil
Oncoclinicas Rio de Janeiro S A, Rio de Janeiro, , Brazil
Instituto D Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, , Brazil
Nucleo de Oncologia da Bahia, Salvador, , Brazil
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo Andre, , Brazil
Impar Servicos Hospitalares SA - Hospital Nove de Julho, Sao Paulo, , Brazil
Núcleo de Pesquisa São Camilo, São Paulo, , Brazil
Onco Star SP Oncologia Ltda, São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo, , Brazil
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Beijing Shijitan Hospital, Capital Medical University, Beijing, , China
Beijing Friendship Hospital Capital Medical University, Beijing, , China
Peking University Third Hospital, Beijing, , China
Beijing Chest hospital, Capital medical university, Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Jilin cancer hospital, Changchun, , China
The First People's Hospital Of Changzhou, Changzhou, , China
Sichuan Cancer Hospital, Chengdu, , China
West China Hospital Sichuan University, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
Southwest Hospital, ChongQing, , China
First Affiliated Hospital of Gannan Medical University, Ganzhou, , China
The First Affiliated Hospital Sun Yat sen University, Guang Zhou, , China
Sun Yat-Sen Memorial Hospital Sun Yat-sen University, Guangzhou, , China
Zhejiang Cancer Hospital, Hang Zhou, , China
The Second Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, , China
Harbin medical university cancer hospital, Harbin, , China
Huizhou Municipal Central Hospital, Huizhou, , China
Huizhou First Hospital, Huizhou, , China
Liuzhou people's Hospital, Liuzhou, , China
Affiliated Hospital of North Sichuan Medical College, Nanchong, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Shenzhen People s Hospital, Shen Zhen Shi, , China
Shengjing Hospital of China Medical University, Shenyang, , China
Shenzhen university General Hospital, Shenzhen, , China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology, Wuhan, , China
The First Affiliated Hospital of Xian Jiaotong University, XI An, , China
Xiangyang Central Hospital, Xiangyang, , China
Yantai Yuhuangding Hospital, Yantai, , China
Henan Cancer Hospital, Zhengzhou, , China
CHU Grenoble, La Tronche, , France
Institute Coeur Poumon, Lille, , France
CHU de Limoges Hopital Dupuytren, Limoges, , France
Hopital Nord, Marseille Cedex 20, , France
Evangelische Lungenklinik Berlin, Berlin, , Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg, Georgsmarienhütte, , Germany
Universitaetsklinikum Giessen und Marburg GmbH, Giessen, , Germany
Munster University Hospital, Münster, , Germany
Oncologianova GmbH, Recklinghausen, , Germany
Onkologische Schwerpunktpraxis, Weinsberg, , Germany
Rambam Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Meir Medical Center, Kfar Saba, , Israel
Rabin Medical Center, Petah-Tikva, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II, Bari, , Italy
A O U Sant Orsola Malpighi, Bologna, , Italy
European Institute of Oncology, Milano, , Italy
Aou San Luigi Gonzaga, Orbassano, , Italy
Istituto Oncologico Veneto - IRCCS, Padova, , Italy
Ospedale S. Maria Delle Croci, Ravenna, , Italy
A.O. San Camillo Forlanini, Roma, , Italy
Istituto Nazionale Tumori Regina Elena, Rome, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
National Cancer Center Hospital, Chuo Ku, , Japan
National Hospital Organization Himeji Medical Center, Himeji, , Japan
Kansai Medical University Hospital, Hirakata, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Kurashiki Central Hospital, Kurashiki, , Japan
Kurume University Hospital, Kurume, , Japan
Matsusaka Municipal Hospital, Matsusaka, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Hokkaido University Hospital, Sapporo-shi, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Fujita Health University Hospital, Toyoake, , Japan
National Hospital Organization Osaka Toneyama Medical Center, Toyonaka-shi, , Japan
Wakayama Medical University Hospital, Wakayama, , Japan
National Hospital Organization Iwakuni Clinical Center, Yamaguchi, , Japan
National Hospital Organization Yamaguchi Ube Medical Center, Yamaguchi, , Japan
National Cancer Center, Gyeonggi-do, , Korea, Republic of
CHA Bundang Medical Center, CHA University, Gyeonggi-do, , Korea, Republic of
GyeongSang National University Hospital, Gyeongsangnam-do, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Prince Court Medical Centre, Kuala Lumpur, , Malaysia
Pantai Hospital Kuala Lumpur, Kuala Lumpur, , Malaysia
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Hospital Umum Sarawak, Kuching, , Malaysia
Beacon Hospital Sdn Bhd, Petaling Jaya, , Malaysia
Sunway Medical Centre, Petaling Jaya, , Malaysia
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
Krakowski Szpital Specjalityczny im. Jana Pawla II, Krakow, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc, Otwock, , Poland
Private Specialist Hospitals - MedPolonia, Poznan, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warszawa, , Poland
Hospital de Braga, Braga, , Portugal
Hospital da Luz, SA, Lisboa, , Portugal
Hosp. Cuf Descobertas, Lisboa, , Portugal
Hospital Pedro Hispano, Senhora da Hora,, , Portugal
Hosp. Univ. A Coruna, A Coruna, , Spain
Hosp. Gral. Univ. de Alicante, Alicante, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. Clinic de Barcelona, Barcelona, , Spain
Hosp. Univ. Quiron Dexeus, Barcelona, , Spain
Hosp. Reina Sofia, Córdoba, , Spain
Hosp. Univ. Insular de Gran Canaria, Las Palmas de Gran Canaria, , Spain
Hosp. Univ. Lucus Augusti, Lugo, , Spain
Hosp. Gral. Univ. Gregorio Maranon, Madrid, , Spain
Hosp. Univ. La Paz, Madrid, , Spain
Hosp. Univ. Pta. de Hierro Majadahonda, Majadahonda, , Spain
Hosp. Regional Univ. de Malaga, Málaga, , Spain
Hosp. Univ. Central de Asturias, Oviedo, , Spain
Hosp. Univ. Son Espases, Palma de Mallorca, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Hosp. Univ. I Politecni La Fe, Valencia, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
Chang Kung Memorial Hospital, Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Chung Shan Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Cancer Center, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Phramongkutklao Hospital and Medical College, Bangkok, , Thailand
Siriraj Hospital, Bangkok, , Thailand
Chiang Mai University, Chiangmai, , Thailand
Adana City Hospital, Adana, , Turkey
Adana Baskent Hospital, Adana, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Gazi University Hospital, Ankara, , Turkey
Ankara Bilkent City Hospital, Ankara, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Istanbul University Cerrahpasa Medical Faculty, Istanbul, , Turkey
Acıbadem Maslak Hospital, Istanbul, , Turkey
Dokuz Eylul University Medical Faculty, Izmir, , Turkey
IEU Medical Point Hospital, Izmir, , Turkey
Medical Park Samsun Hastanesi, Samsun, , Turkey
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
Imperial College Healthcare, London, , United Kingdom
Newcastle Freeman Hospital, Newcastle Upon Tyne, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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