비소세포폐암에서 표준 치료 도세탁셀에 비해 아카순리맙과 펨브롤리주맙 병용의 우월성을 평가하기 위한 시험(ABBIL1TY NSCLC-06)
PD-1/PD-L1 억제제 및 백금 함유 화학요법(ABBIL1TY NSCLC-06)
This is a multicenter, randomized, open-label, international, Phase 3 trial to evaluate the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel (standard of care) in participants with locally advanced (unresectable stage IIIB/C) or programmed death ligand 1 (PD-L1)-positive metastatic non-small cell lung cancer (NSCLC) who have been treated with programmed cell death protein 1 (PD-1)/PD-L1 inhibitor and platinum-containing chemotherapy, administered either in combination or sequentially in the locally advanced (unresectable stage IIIB/C) or metastatic setting.
연구 개요
상태
상세 설명
The goal of this trial is to determine the efficacy and safety of acasunlimab (an experimental antibody also known as GEN1046 or DuoBody® PDL1x4-1BB) in combination with pembrolizumab (an antibody known as KEYTRUDA®) compared to that of docetaxel (a standard of care chemotherapy). During the trial, the participant's quality of life will also be evaluated using industry-standard scales of measurement. To be eligible, participants must have:
- non-small cell lung cancer that are locally advanced, unresectable stage IIIB/C or has metastasized (spread)
- tumors that are positive for the PD-L1 protein (a biomarker that may be predictive of response to therapy)
- been previously treated with a PD-1/PD-L1-inhibitor and a platinum-containing cancer therapy administered in combination or sequentially (irrespective of the order).
Other eligibility criteria will also apply.
Participants will be assigned to 1 of 2 active therapies, also known as treatment arms, as follows:
- Acasunlimab (100 milligrams [mg]) and pembrolizumab (400 mg) once every 6 weeks (Q6W), or
- Docetaxel 75 milligrams per meter squared (mg/m^2) once every 3 weeks (Q3W).
The estimated trial duration for a participant will vary but may be up to 5 years, consisting of:
- An optional 3-month pre-screening period
- A 28-day screening period
- Up to 2 years of treatment
- A 90-day safety follow-up period
- Post-treatment follow-up.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
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Athens, 그리스
- Alexandra General Hospital
-
Athens, 그리스
- University General Hospital Attikon
-
Athens, 그리스
- Henry Dunant Hospital Center
-
Heraklion, 그리스
- University General Hospital of Heraklion
-
Larissa, 그리스
- University General Hospital of Larissa
-
Thessaloniki, 그리스
- Interbalkan Hospital of Thessaloniki
-
Thessaloniki, 그리스
- Bioclinic Thessaloniki
-
-
-
-
-
Amsterdam, 네덜란드
- Antoni van Leeuwenhoek
-
Amsterdam, 네덜란드
- Amsterdam UMC Locatie VUMC
-
Harderwijk, 네덜란드
- St. Jansdal Ziekenhuis
-
Heerlen, 네덜란드
- Zuyderland Medisch Centrum - Heerlen
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Leiden, 네덜란드
- Leiden University Medical Center
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Nijmegen, 네덜란드
- Radboudumc
-
Rotterdam, 네덜란드
- Erasmus Medisch Centrum
-
Utrecht, 네덜란드
- Universitair Medisch Centrum Utrecht
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Zwolle, 네덜란드
- Isala Zwolle
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-
-
-
-
Douliu, 대만
- National Taiwan University Hospital Yunlin Branch
-
Tainan, 대만
- National Cheng Kung University Hospital
-
Taipei, 대만
- Taipei Veterans General Hospital
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Taipei, 대만
- National Taiwan University Cancer Center
-
Taoyuan City, 대만
- Chang Gung Memorial Hospital,Linkou
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-
-
-
-
Cheongju-si, 대한민국
- Chungbuk National University Hospital
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Daegu, 대한민국
- Keimyung University Dongsan Hospital
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Goyang-si, 대한민국
- National Cancer Center Korea
-
Seoul, 대한민국
- Asan Medical Center
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Seoul, 대한민국
- Samsung Medical Center
-
Seoul, 대한민국
- Severance Hospital, Yonsei University Health System
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-
Gyeonggi-do
-
Suwon, Gyeonggi-do, 대한민국
- Ajou University Hospital
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-
-
-
-
Hamburg, 독일
- Asklepios Klinik Harburg
-
-
Baden-Wurttemberg
-
Esslingen am Neckar, Baden-Wurttemberg, 독일
- Klinikum Esslingen GmbH
-
Heidelberg, Baden-Wurttemberg, 독일
- Thoraxklinik Heidelberg gGmbH
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-
Lower Saxony
-
Göttingen, Lower Saxony, 독일
- Universitaetsmedizin Goettingen
-
Hanover, Lower Saxony, 독일
- MHH Medizinische Hochschule Hannover
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-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, 독일
- Johannes Gutenberg University Mainz
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-
Saxony
-
Dresden, Saxony, 독일
- Universitatsklinikum Carl Gustav Carus Dresden
-
-
Saxony-Anhalt
-
Halle, Saxony-Anhalt, 독일
- MVZ Martha-Maria Halle-Doelau
-
-
Schleswig-Holstein
-
Großhansdorf, Schleswig-Holstein, 독일
- LungenClinic Grosshansdorf GmbH
-
-
State of Berlin
-
Berlin, State of Berlin, 독일
- Vivantes Klinikum Neukoelln
-
Berlin, State of Berlin, 독일
- Evangelische Lungenklinik Berlin
-
Berlin, State of Berlin, 독일
- Vivantes Klinikum im Friedrichshain
-
Berlin, State of Berlin, 독일
- Vivantes Klinikum Spandau
-
-
-
-
Arizona
-
Tucson, Arizona, 미국, 85712
- Arizona Blood and Cancer Specialists
-
-
California
-
Los Angeles, California, 미국, 90089
- Usc Norris Comprehensive Cancer Center
-
Vallejo, California, 미국, 94589
- Kaiser Permanente Vallejo Medical Center
-
-
Florida
-
Ocala, Florida, 미국, 34474
- Ocala Oncology Center P.L.
-
Orlando, Florida, 미국, 32806
- Orlando Regional Medical Center
-
-
Georgia
-
Athens, Georgia, 미국, 30607
- University Cancer & Blood Center, LLC
-
Atlanta, Georgia, 미국, 30318
- Piedmont Cancer Institute Atlanta
-
Atlanta, Georgia, 미국, 30328
- Piedmont Cancer Institute - Sandy Springs (Atlanta) Office
-
Fayetteville, Georgia, 미국, 30214
- Piedmont Cancer Institute - Fayetteville Office
-
Newnan, Georgia, 미국, 30265
- Piedmont Cancer Institute - Newnan Office
-
Stockbridge, Georgia, 미국, 30281
- Piedmont Cancer Institute - Stockbridge Office
-
-
Hawaii
-
Honolulu, Hawaii, 미국, 96817
- Kaiser Foundation Hospitals
-
-
Illinois
-
Chicago, Illinois, 미국, 60612
- University of Illinois
-
-
Indiana
-
Indianapolis, Indiana, 미국, 46219
- Community Cancer Center East Medical Oncology Hematology
-
-
Kentucky
-
Lexington, Kentucky, 미국, 40503
- Baptist Health Lexington
-
Louisville, Kentucky, 미국, 40202
- Norton Cancer Institute
-
Pikeville, Kentucky, 미국, 41501
- Pikeville Medical Center
-
-
Missouri
-
St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
-
-
Nebraska
-
Grand Island, Nebraska, 미국, 68803
- St. Francis Hospital - Grand Island
-
Omaha, Nebraska, 미국, 68124
- Oncology Hematology West
-
Omaha, Nebraska, 미국, 68130
- Oncology Hematology West, PC dba Nebraska Cancer Specialists
-
-
New York
-
Stony Brook, New York, 미국, 11790
- Stony Brook University Medical Center|University Medical Center
-
-
North Carolina
-
Charlotte, North Carolina, 미국, 28204
- Novant Health Pharmacy
-
Winston-Salem, North Carolina, 미국, 27103
- Novant Health Oncology Specialists
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania Health System
-
Pittsburgh, Pennsylvania, 미국, 15212
- Allegheny General Hospital
-
-
South Dakota
-
Sioux Falls, South Dakota, 미국, 57105
- Avera Cancer Institute
-
-
Tennessee
-
Chattanooga, Tennessee, 미국, 37404
- Parkridge Medical Center
-
Knoxville, Tennessee, 미국, 37920
- University of Tennessee Medical Center Cancer Institute
-
Nashville, Tennessee, 미국, 37205
- Tennessee Oncology
-
Nashville, Tennessee, 미국, 37203
- Midtown Tennessee Oncology
-
-
Texas
-
Austin, Texas, 미국, 78705
- Texas Oncology-Austin Midtown
-
Austin, Texas, 미국, 78731
- Texas Oncology-Austin Central
-
Austin, Texas, 미국, 78745
- South Austin Cancer Ctr
-
-
Virginia
-
Charlottesville, Virginia, 미국, 22903
- University of Virginia Hematology and Oncology
-
-
Washington
-
Seattle, Washington, 미국, 98104
- Cancer Institute At Swedish Med Ctr
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-
-
-
-
Brussels, 벨기에
- C. H. U. St-Pierre
-
Brussels, 벨기에
- Universitair Ziekenhuis Bruxelles
-
Brussels, 벨기에
- Cliniques Universitaires Saint-Luc
-
Gilly, 벨기에
- Grand Hôpital de Charleroi
-
Hasselt, 벨기에
- Jessa Ziekenhuis Hospital
-
Liège, 벨기에
- CHU de Liège
-
Mechelen, 벨기에
- AZ Sint-Maarten
-
Roeselare, 벨기에
- AZ Delta
-
-
-
-
-
Pleven, 불가리아
- MHAT Heart and Brain - Pleven
-
Plovdiv, 불가리아
- Complex Oncology Center - Plovdiv, EOOD
-
Sofia, 불가리아
- UMHAT "Sv. Ivan Rilski", EAD
-
Sofia, 불가리아
- MHAT for women's health - Nadezhda, OOD
-
Sofia, 불가리아
- MHAT "Serdika", EOOD
-
Sofia, 불가리아
- UMHAT 'SofiaMed', OOD
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-
-
-
-
Belo Horizonte, 브라질
- Oncoclínicas do Brasil Serviços Médicos SA
-
Porto Alegre, 브라질
- Hospital Ernesto Dornelles
-
Rio de Janeiro, 브라질
- Oncoclínicas Rio de Janeiro
-
Santo André, 브라질
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
-
-
Paraná
-
Curitiba, Paraná, 브라질
- Hospital Erasto Gaertner
-
-
Pernambuco
-
Recife, Pernambuco, 브라질
- MultiHemo Servicos Medicos
-
-
Rio Do Janeiro
-
Rio de Janeiro, Rio Do Janeiro, 브라질
- Instituto D'Or Pesquisa e Ensino - Rio de Janeiro
-
-
Rio Grande Do Su
-
Porto Alegre, Rio Grande Do Su, 브라질
- Hospital São Lucas da PUCRS
-
-
Rio Grande do Sul
-
Ijuí, Rio Grande do Sul, 브라질
- Hospital de Clinicas de Ijui
-
Porto Alegre, Rio Grande do Sul, 브라질
- Centro Gaucho Integrado - Mae de Deus Center
-
-
Santa Catarina
-
Itajaí, Santa Catarina, 브라질
- Clínica de Neoplasias Litoral Ltda.
-
-
São Paulo
-
São Paulo, São Paulo, 브라질
- BP A Beneficencia Portuguesa de Sao Paulo
-
São Paulo, São Paulo, 브라질
- Centro Paulista de Oncologia S.A.
-
São Paulo, São Paulo, 브라질
- Hospital Sirio-Libanes
-
-
-
-
-
Madrid, 스페인
- Hospital Universitario HM Sanchinarro
-
Madrid, 스페인
- Facility name: Clínica Universidad de Navarra
-
Málaga, 스페인
- Hospital Quironsalud Malaga
-
Valencia, 스페인
- IVO - Instituto Valenciano de Oncologia
-
-
Alicante
-
Alicante, Alicante, 스페인
- Hospital General Universitario Dr. Balmis
-
-
Barcelona
-
Barcelona, Barcelona, 스페인
- Hospital Universitari Vall d'Hebron
-
L'Hospitalet de Llobregat, Barcelona, 스페인
- ICO l'Hospitalet
-
-
Córdoba
-
Córdoba, Córdoba, 스페인
- Hospital Universitario Reina Sofia
-
-
Girona
-
Girona, Girona, 스페인
- ICO Girona
-
-
La Coruña
-
Santiago de Compostela, La Coruña, 스페인
- Complejo Hospitalario Universitario de Santiago CHUS
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, 스페인
- Complejo Hospitalario Universitario Insular Materno-Infantil
-
-
Madrid
-
Madrid, Madrid, 스페인
- Hospital Universitario 12 de Octubre
-
Madrid, Madrid, 스페인
- Hospital General Universitario Gregorio Marañon
-
Pozuelo de Alarcón, Madrid, 스페인
- Hospital Universitario Quironsalud Madrid
-
-
Málaga
-
Marbella, Málaga, 스페인
- H.C. Hospitales S.L.
-
Málaga, Málaga, 스페인
- Hospital Universitario Virgen de la Victoria
-
-
Navarre
-
Pamplona, Navarre, 스페인
- Clinica Universidad de Navarra
-
-
Sevilla
-
Seville, Sevilla, 스페인
- Hospital Universitario Virgen Macarena
-
Seville, Sevilla, 스페인
- Hospital Universitario Virgen del Rocio
-
-
Valencia
-
Valencia, Valencia, 스페인
- Hospital Universitari i Politecnic La Fe
-
-
-
-
-
Ciudad Autonoma Buenos Aires, 아르헨티나
- Hospital Italiano de Buenos Aires
-
La Rioja, 아르헨티나
- Investigaciones CORI S.R.L.
-
-
Buenos Aires
-
La Plata, Buenos Aires, 아르헨티나
- Hospital Italiano de La Plata
-
Pergamino, Buenos Aires, 아르헨티나
- Centro de Investigacion Pergamino S.A.
-
-
Ciudad Autonoma Buenos Aires
-
Buenos Aires, Ciudad Autonoma Buenos Aires, 아르헨티나
- Instituto Medico Especializado Alexander Fleming
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, 아르헨티나
- Sanatorio Parque S.A.
-
-
-
-
-
Cork, 아일랜드
- Cork University Hospital
-
Dublin, 아일랜드
- St Vincent's University Hospital
-
Limerick, 아일랜드
- University Hospital Limerick
-
Waterford, 아일랜드
- Waterford Regional Hospital
-
-
Dublin
-
Dublin, Dublin, 아일랜드
- Beaumont Hospital
-
Dublin, Dublin, 아일랜드
- St James's Hospital
-
-
-
-
-
Tallinn, 에스토니아
- North Estonia Medical Centre Foundation
-
Tartu, 에스토니아
- Tartu University Hospital
-
-
-
-
-
London, 영국
- Guy's Hospital
-
London, 영국
- Barts Hospital
-
Manchester, 영국
- The Christie Hospital
-
Nottingham, 영국
- Nottingham University Hospitals City Campus
-
Plymouth, 영국
- Derriford Hospital
-
-
Strathclyde
-
Glasgow, Strathclyde, 영국
- Beatson West of Scotland Cancer Care
-
-
-
-
-
Linz, 오스트리아
- Kepler Universitatsklinikum Med Campus III
-
Rankweil, 오스트리아
- LKH - Rankweil
-
Vienna, 오스트리아
- Standort Penzing der Klinik Ottakring
-
Vienna, 오스트리아
- Wiener Gesundheitsverbund - Klinik Floridsdorf
-
-
-
-
-
Bergamo, 이탈리아
- ASST Papa Giovanni XXIII
-
Candiolo, 이탈리아
- Istituto di Candiolo
-
Meldola, 이탈리아
- IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
-
Milan, 이탈리아
- IRCCS Istituto Nazionale dei Tumori
-
-
Genova
-
Genova, Genova, 이탈리아
- Istituto Nazionale per la Ricerca sul Cancro di Genova
-
-
Milano
-
Monza, Milano, 이탈리아
- Fondazione IRCCS San Gerardo dei Tintori
-
Rozzano, Milano, 이탈리아
- Istituto Clinico Humanitas
-
-
Napoli
-
Naples, Napoli, 이탈리아
- AOU Università degli Studi della Campania "Luigi Vanvitelli"
-
-
Pordenone
-
Aviano, Pordenone, 이탈리아
- IRCCS Centro di Riferimento Oncologico
-
-
Ravenna
-
Ravenna, Ravenna, 이탈리아
- Ospedale Santa Maria delle Croci
-
-
Roma
-
Roma, Roma, 이탈리아
- Regina Elena National Cancer Institute
-
Rome, Roma, 이탈리아
- IRCCS Policlinico Universitario Agostino Gemelli
-
-
Torino
-
Orbassano, Torino, 이탈리아
- AOU San Luigi Gonzaga
-
-
Verona
-
Verona, Verona, 이탈리아
- CRC - Centro Ricerche Cliniche di Verona S.r.l.
-
-
-
-
-
Bunkyō City, 일본
- Nippon Medical School Hospital
-
Chūōku, 일본
- National Cancer Center Hospital
-
Fukuoka, 일본
- NHO Kyushu Cancer Center
-
Hokkaido, 일본
- NHO Hokkaido Cancer Center
-
Kurashiki-shi, 일본
- Kurashiki Central Hospital
-
Kurume-shi, 일본
- Kurume University Hospital
-
Kōtō City, 일본
- Cancer Institute Hospital of JFCR
-
Nagoya, 일본
- Aichi Cancer Center Hospital
-
Nagoya, 일본
- NHO Nagoya Medical Center
-
Natori-shi, 일본
- Miyagi Cancer Center
-
Okayama, 일본
- Okayama University Hospital
-
Osaka, 일본
- Osaka International Cancer Institute
-
Osaka, 일본
- Osaka Medical and Pharmaceutical University Hospital
-
Ota-shi, 일본
- Gunma Prefectural Cancer Center
-
Yokohama, 일본
- Kanagawa Cancer Center
-
-
Ehime
-
Matsuyama, Ehime, 일본
- Shikoku Cancer Center
-
-
Fukuoka
-
Kitakyushu-shi, Fukuoka, 일본
- JCHO Kyushu Hospital
-
-
Hiroshima
-
Hiroshima, Hiroshima, 일본
- Hiroshima University Hospital
-
-
Hyōgo
-
Kobe, Hyōgo, 일본
- Kobe Minimally Invasive Cancer Center
-
-
Kumamoto
-
Kumamoto, Kumamoto, 일본
- Saiseikai Kumamoto Hospital
-
-
Osaka
-
Osakasayama-shi, Osaka, 일본
- Kindai University Hospital
-
-
Tokyo-To
-
Bunkyō City, Tokyo-To, 일본
- Juntendo University Hospital
-
-
-
-
-
Providencia, 칠레
- FALP - Fundación Arturo López Pérez
-
Santiago, 칠레
- Centro de Investigacion Clinica Bradford Hill
-
Santiago, 칠레
- IRAM - Instituto de Radio Medicina
-
Viña del Mar, 칠레
- Oncocentro APYS
-
-
-
-
Ontario
-
Brampton, Ontario, 캐나다
- William Osler Health System-Brampton Civic Hospital|William Osler Health System
-
Kingston, Ontario, 캐나다
- Kingston Health Sciences Centre
-
Toronto, Ontario, 캐나다
- Princess Margaret Cancer Centre - University Health Network
-
-
Quebec
-
Montreal, Quebec, 캐나다
- MUHC - Jewish General Hospital
-
-
-
-
-
Dubrovnik, 크로아티아
- General Hospital Dubrovnik
-
Rijeka, 크로아티아
- Specialty Hospital Medico
-
Zagreb, 크로아티아
- Sestre milosrdnice University Hospital Center
-
Zagreb, 크로아티아
- Department for Pulmonary Diseases University Hospital Centre Zagreb
-
-
-
-
-
Adana, 터키 (Türkiye)
- Adana City Hospital
-
Adana, 터키 (Türkiye)
- Medical Park Seyhan Hospital
-
Ankara, 터키 (Türkiye)
- Gulhane Training and Research Hospital
-
Ankara, 터키 (Türkiye)
- Ankara City Hospital
-
Ankara, 터키 (Türkiye)
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Ankara, 터키 (Türkiye)
- Liv Hospital Ankara
-
Istanbul, 터키 (Türkiye)
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Istanbul, 터키 (Türkiye)
- Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
-
Izmir, 터키 (Türkiye)
- İ.E.Ü. Medicalpoint İzmir Hastanesi
-
-
-
-
-
Coimbra, 포르투갈
- Unidade Local de Saude de Coimbra E P E
-
Matosinhos Municipality, 포르투갈
- Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano
-
Porto, 포르투갈
- Hospital CUF Porto
-
Setúbal, 포르투갈
- Unidade Local de Saude da Arrabida E. P. E
-
-
-
-
-
Koszalin, 폴란드
- Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
-
Krakow, 폴란드
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
-
Lodz, 폴란드
- Polish Mother's Memorial Hospital (Instytut Centrum Zdrowia Matki Polki)
-
Skorzewo, 폴란드
- Aidport sp z o.o.
-
Warsaw, 폴란드
- Instytut Gruzlicy i Chorob Pluc w Warszawie
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Warsaw, 폴란드
- Maria Sklodowska-Curie National Research Institute of Oncology (Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie)
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Puerto Rico
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San Juan, Puerto Rico, 푸에르토 리코, 902
- Pan American Oncology Trials, LLC
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San Juan, Puerto Rico, 푸에르토 리코, 917
- Auxilio Mutuo Cancer Center
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Angers, 프랑스
- CHU Angers - Hôpital Larrey
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Bayonne, 프랑스
- Centre Hospitalier de la côte Basque
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Boulogne-Billancourt, 프랑스
- Hôpital Ambroise Paré
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Créteil, 프랑스
- Centre Hospitalier Intercommunal de Creteil (CHIC)
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Lille, 프랑스
- Hopital Albert Calmette - CHU Lille
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Lyon, 프랑스
- Centre Léon Bérard
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Marseille, 프랑스
- Assistance Publique-Hôpitaux de Marseille
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Mulhouse, 프랑스
- CH de Mulhouse - Hôpital Emile Muller
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Nantes, 프랑스
- Hôpital Privé du Confluent
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Paris, 프랑스
- Institut Curie
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Rennes, 프랑스
- CHU Rennes - Hopital Pontchaillou
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Saint-Herblain, 프랑스
- ICO - Site René Gauducheau
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Toulon, 프랑스
- Hôpital Sainte Musse
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, 프랑스
- Institut Paoli Calmettes
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Gironde
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Bordeaux, Gironde, 프랑스
- Institut Bergonié
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Paris
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Paris, Paris, 프랑스
- Hopital Saint Joseph - Paris
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Pyrenees Atlantiques
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Bayonne, Pyrenees Atlantiques, 프랑스
- Clinique Belharra
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Vaculuse
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Avignon, Vaculuse, 프랑스
- Institut Sainte Catherine
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Val de Marne
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Villejuif, Val de Marne, 프랑스
- Institut Gustave Roussy
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Budapest, 헝가리
- Orszagos Koranyi Pulmonologiai Intezet
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Kecskemét, 헝가리
- Bács-Kiskun County Hospital BKMK
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-
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Fitzroy, 호주
- St Vincent's Hospital Melbourne
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Wendouree, 호주
- Ballarat Oncology & Haematology Service
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New South Wales
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Camperdown, New South Wales, 호주
- Chris OBrien LifeHouse
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Sydney, New South Wales, 호주
- Westmead Hospital
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Queensland
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Southport, Queensland, 호주
- Gold Coast Hospital
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South Australia
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Bedford Park, South Australia, 호주
- Flinders Medical Centre
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Western Australia
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Perth, Western Australia, 호주
- Sir Charles Gairdner Hospital
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Subiaco, Western Australia, 호주
- St John of God Subiaco Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
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Participant has histologically or cytologically confirmed locally advanced (unresectable stage IIIB/C) or metastatic NSCLC (stage IV) with known subtype.
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Participant has progressed radiographically on or after receiving:
- One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the locally advanced (unresectable stage IIIB/C) or metastatic disease setting; OR
- No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the locally advanced (unresectable stage IIIB/C) or metastatic disease setting.
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Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the locally advanced (unresectable stage IIIB/C) or metastatic setting at a sponsor-designated central laboratory.
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Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
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Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.
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Participant has a life expectancy of ≥3 months.
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Participant must have adequate organ and bone marrow function, per laboratory test results within 7 days of trial treatment.
Key Exclusion Criteria:
-
Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten rat sarcoma virus (KRAS), B-Raf proto-oncogene (BRAF) mutations, and MET proto-oncogene; receptor tyrosine kinase (MET) exon 14 skipping mutations/MET amplification. NOTE: MET amplification testing is optional based on local availability of the test.
- Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to targeted therapies.
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Participants with newly identified, untreated or unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
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Prior treatment with docetaxel for NSCLC.
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Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
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Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm A
Acasunlimab, 100 mg and pembrolizumab, 400 mg will be administered via intravenous (IV) infusion, once every 6 weeks (Q6W) (Cycle length=42 days). |
IV infusion
다른 이름들:
IV infusion |
|
활성 비교기: Arm B
Docetaxel, 75 mg/m^2 will be administered via IV infusion, once every 3 weeks (Q3W) (Cycle length=21 days). |
IV infusion |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: Up to approximately 5 years
|
OS is defined as the time from date of randomization to date of death due to any cause. |
Up to approximately 5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
부작용(AE)이 발생한 참가자 수
기간: 첫 번째 투여부터 연구 종료까지(약 5년)
|
첫 번째 투여부터 연구 종료까지(약 5년)
|
|
|
AE로 인한 치료 중단 시간
기간: 첫 번째 복용량에서 연구 종료 (약 5 년)
|
첫 번째 복용량에서 연구 종료 (약 5 년)
|
|
|
아카순리맙의 혈장 농도
기간: 사이클 1-4에서 투여 전 및 투여 후 다중 시점에서 (사이클 길이=42일)
|
사이클 1-4에서 투여 전 및 투여 후 다중 시점에서 (사이클 길이=42일)
|
|
|
Progression-Free Survival (PFS)
기간: Up to approximately 5 years
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator. |
Up to approximately 5 years
|
|
Confirmed Overall Response Rate (ORR)
기간: Up to approximately 5 years
|
Confirmed ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator. |
Up to approximately 5 years
|
|
Duration of Response (DOR)
기간: Up to approximately 5 years
|
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator. |
Up to approximately 5 years
|
|
Number of Participants With Anti-drug Antibodies (ADAs) to Acasunlimab
기간: Predose and postdose at multiple timepoints in Cycles 1-4 (Cycle length=42 days)
|
Serum samples will be analyzed using validated, specific, and sensitive immunoassay method. Samples will be screened for ADAs binding to acasunlimab and the titer of confirmed positive/negative samples will be reported. |
Predose and postdose at multiple timepoints in Cycles 1-4 (Cycle length=42 days)
|
|
Change From Baseline in Functional Assessment of Cancer Therapy Item GP5 (FACIT-GP5; Version 4) Score
기간: Baseline up to approximately 2 years
|
Participant's global assessment of treatment tolerability will be assessed by FACIT-GP5. FACIT-GP5 asks participants to rate their agreement with the following statement, "I am bothered by side effects of treatment" in the past 7 days. Responses will be captured on a 5-point Likert scale ranging from 0 to 4 indicating 0 as not at all to 4 as very much bothered by side effects. |
Baseline up to approximately 2 years
|
|
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
기간: Up to approximately 2 years
|
The PRO-CTCAE allows participants to report on the frequency, severity, and interference of patient-reported symptoms. For each AE, there are between one and three items to assess the frequency, severity, and/or interference with activities related to that AE. All PRO-CTCAE responses will be scored from 0 to 4 for frequency indicating (0= never to 4= almost constantly), severity (0= none to 4= very severe) and interference with usual or daily activities (0= not at all to 4= very much). |
Up to approximately 2 years
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Study Official, Genmab
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- GCT1046-06
- 2024-512998-27-00 (씨티스)
- jRCT2051240178 (레지스트리 식별자: Japan Registry of Clinical Trials)
- 1010602 (레지스트리 식별자: UK Research Summary Database)
- NL-OMON57246 (레지스트리 식별자: NL CCMO)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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