재발성 소세포폐암(LAGOON) 환자에서 단일 제제 또는 이리노테칸과 토포테칸 또는 이리노테칸의 병용요법으로서의 루르비넥테딘의 임상 시험
재발된 소세포폐암 환자에서 루르비넥테딘 단일 제제 또는 이리노테칸 대 조사자의 선택(토포테칸 또는 이리노테칸)과 병용한 루르비넥테딘의 무작위, 다기관, 공개 라벨, III상 연구(LAGOON 시험)
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Approximately 705 Adult SCLC patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 who have failed one prior platinum-containing line with CTFI ≥ 30 days and controlled asymptomatic and pretreated Central Nervous System metastases will be enrolled and assigned to each treatment arm.
Central randomization will be implemented; patients will be assigned to each treatment arm at a 1:1:1 ratio.
An Independent Data Monitoring Committee (IDMC) will oversee the conduct of the study. The IDMC should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Batumi, 그루지야, 6000
- High Technology Hospital Medcenter
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Tbilisi, 그루지야, 112
- Todua Clinic
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Tbilisi, 그루지야, 114
- New Hospitals
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Tbilisi, 그루지야, 179
- JSC Evex Hospitals "Caraps Medline"
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Tbilisi, 그루지야, 186
- LTD Cancer Research Centre
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Tbilisi, 그루지야, 156
- Institute Of Clinical Oncology
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Taipei, 대만, 106
- National Taiwan University Cancer Center
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Chang Hua
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Chang-hua, Chang Hua, 대만, 500
- Changhua Christian Hospital
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Chiayi
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Dalin, Chiayi, 대만, 622401
- Buddhist Dalin Tzu Chi Hospital
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Kaohsiung
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Kaohsiung City, Kaohsiung, 대만, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Cheongju-si, 대한민국, 28644
- Chungbuk National University Hospital
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Gyeonggi-do, 대한민국, 13496
- CHA Bundang Medical Center, CHA University
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Gyeonggi-do, 대한민국, 16247
- The Catholic University of Korea, St.Vincents Hospital
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Incheon, 대한민국, 21565
- Gachon University Gil Medical Center
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Incheon, 대한민국, 22332
- Inha University Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center
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Seoul, 대한민국, 03181
- Kangbuk Samsung Hospital
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Seoul, 대한민국, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, 대한민국, 07061
- Seoul Metropolitan Government-Seoul National University Boramae Medical Center
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Aalborg, 덴마크, 9000
- Aalborg University Hospital
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Næstved, 덴마크, 4700
- Sjællands Universitetshospital
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Sønderborg, 덴마크, 6400
- Sønderborg Sygehus
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Vejle, 덴마크, 7100
- Vejle Hospital
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Bad Berka, 독일, 99437
- Zentralklinik Bad Berka GmbH
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Berlin, 독일, 13125
- Evangelische Lungenklinik Berlin
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Bremen, 독일, 28325
- Klinikum Bremen Ost
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Duisburg, 독일, 74166
- Helios St. Johannes Klinikum
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Esslingen am Neckar, 독일, 73730
- Klinikum Esslingen GmbH
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Freiburg im Breisgau, 독일, 79106
- Universittsklinikum Freiburg
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Gauting, 독일, 82131
- Asklepios Fachklinik München-Gauting
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Halle, 독일, 06120
- Universitaetsklinikum Halle Saale
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Halle, 독일, 06120
- Krankenhaus Martha-Maria Halle gGmbH
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Heidelberg, 독일, 69126
- Thoraxclinic Heidelberg GmbH
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Karlsruhe, 독일, 76137
- Vincentius-Diakonissen-Kliniken gAG Karlsruhe
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Kassel, 독일, 34125
- Klinikum Kassel - Medizinische Klinik IV
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Löwenstein, 독일, 74245
- Klinik Loewenstein gGmbH
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Mannheim, 독일, 68167
- Universitaetsmedizin Mannheim
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München, 독일, 81925
- Staedtisches Klinikum München - Bogenhausen
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Offenbach, 독일, 63069
- Sana Klinikum Offenbach
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Schleswig-Holstein
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Großhansdorf, Schleswig-Holstein, 독일, 22927
- LungenClinic Grosshansdorf
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Baia Mare, 루마니아, 020945
- Sc Oncopremium Team Srl
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Cluj-Napoca, 루마니아, 400641
- Medisprof srl
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Craiova, 루마니아, 200385
- Oncolab SRL
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Craiova, 루마니아, 200746
- Centrul de Oncologie Sfantu Nectarie
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Ovidiu, 루마니아, 9005900
- Ovidius Clinical Hospital
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Timișoara, 루마니아, 300166
- Oncocenter Oncologie clinica S.R.L
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Arizona
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Chandler, Arizona, 미국, 85224
- Ironwood Cancer & Research Centers
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Arkansas
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Hot Springs, Arkansas, 미국, 71913
- Genesis Cancer and Blood
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Florida
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Fort Myers, Florida, 미국, 33901
- Florida Cancer Specialists - South
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St. Petersburg, Florida, 미국, 33705
- Florida Cancer Specialists - North
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Tallahassee, Florida, 미국, 32308
- Florida Cancer Specialists - Panhandle
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West Palm Beach, Florida, 미국, 33401
- Florida Cancer Specialists - East
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Illinois
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Joliet, Illinois, 미국, 60435
- Duly Health and Care
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Kentucky
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Louisville, Kentucky, 미국, 40202
- Norton Cancer Institue, Downtown
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Dana-Farber Cancer Institute
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Nebraska
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Grand Island, Nebraska, 미국, 68803
- Oncology Hematology West, PC (Grand Island)
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Omaha, Nebraska, 미국, 68130
- Oncology Hematology West, PC dba Nebraska Cancer Specialists
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North Carolina
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Pinehurst, North Carolina, 미국, 28374
- FirstHealth Outpatient Cancer Center
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Utah
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Salt Lake City, Utah, 미국, 84106
- Utah Cancer Specialists
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Washington
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Tacoma, Washington, 미국, 98405
- MultiCare Regional Cancer Center - Tacoma
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Froedtert Hospital/Medical College of Wisconsin
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-
-
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Brasschaat, 벨기에, 2930
- Algemeen Ziekenhuis AZ Klina - Borstkliniek
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Charleroi, 벨기에, 6000
- Grand Hopital de Charleroi GHdC - Hopital Saint Joseph
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Liège, 벨기에, 4000
- CHR de la Citadelle
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Liège, 벨기에, 4000
- Centre Hospitalier Chretien CHC - MontLegia
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Liège, 벨기에, 4000
- CHU Liege
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Mechelen, 벨기에, 2800
- Az Sint Maarten Mechelen
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Mons, 벨기에, 7000
- Centre Hospitalier Universitaire (CHU) Ambroise Pare
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Antwerp
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Edegem, Antwerp, 벨기에, 2650
- Antwerp University Hospital
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Plovdiv, 불가리아, 4000
- Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology
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Sofia, 불가리아, 1303
- Specialized hospital for active treatment of oncological diseases
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Sofia, 불가리아, 1632
- Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology
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Panagyurishte
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Panagyurishte, Panagyurishte, 불가리아, 4500
- Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology
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Barretos, 브라질, SP 14784-400
- Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor
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Ijuí, 브라질, 98700-00
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda
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Rio de Janeiro, 브라질, 20231-050
- Instituto Nacional de Cancer - Ministrio da Sade
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Paraná
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Curitiba, Paraná, 브라질, 82305-100
- Oncocentro-Centro de Oncologia do Parana
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Porto Alegre
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Porto Alegre, Porto Alegre, 브라질, 90050-170
- Irmandade daSanta Casa de Misericordia de Porto Alegre
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Porto Alegre, Porto Alegre, 브라질, 90610-000
- Hospital Sao Lucas da PUCRS
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Santa Cecília, Porto Alegre, 브라질, RS 90035-903
- UPCO - Hospital de Clinicas de Porto Alegre
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Salvador
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Ondina, Salvador, 브라질, BA 40170-110
- Nucleo de Oncologia da Bahia - NOB
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Basel, 스위스, 4031
- University Hospital Basel
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Bellinzona, 스위스, 6500
- Istituto Oncologico della Svizzera Italiana
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Frauenfeld, 스위스, 8501
- Spital Thurgau - Kantonspital Frauenfeld
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Lausanne, 스위스, 1011
- Centre Hospitalier Universitaire Vaudois
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Liestal, 스위스, 4410
- Kantonsspital Baselland
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Münsterlingen, 스위스, 8596
- Spital Thurgau - Kantonsspital Muensterlingen
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Villars-sur-Glâne, 스위스, 1752
- HFR Freiburg Kantonsspital
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A Coruña
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A Coruña, A Coruña, 스페인, 15009
- Hospital Teresa Herrera C.H.U.A.
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Barcelona
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Badalona, Barcelona, 스페인, 08916
- Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol
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Barcelona, Barcelona, 스페인, 08035
- Hospital Universitari Vall d'Hebron
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L'Hospitalet de Llobregat, Barcelona, 스페인, 08908
- Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
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Cantabria
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Santander, Cantabria, 스페인, 39008
- Hospital Universitario Marqués de Valdecilla
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Córdoba
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Córdoba, Córdoba, 스페인, 14004
- Hospital Universitario Reina Sofía
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Gran Canaria
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Las Palmas de Gran Canaria, Gran Canaria, 스페인, 35016
- Complejo Hospitalario Materno-Insular de Gran Canaria
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Lugo
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Lugo, Lugo, 스페인, 27003
- Hospital Universitario Lucus Augusti
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Madrid
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Madrid, Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Marañón
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Madrid, Madrid, 스페인, 28050
- Hospital Universitario HM Sanchinarro
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Madrid, Madrid, 스페인, 28006
- Hospital Universitario La Paz
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Madrid, Madrid, 스페인, 28033
- MD Anderson Cancer Center
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Madrid, Madrid, 스페인, 28027
- Clínica Universidad de Navarra
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Madrid, Madrid, 스페인, 28034
- Hospital Universitario Ramón y Cajal
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Madrid, Madrid, 스페인, 28040
- Hospital Clínico San Carlos
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Madrid, Madrid, 스페인, 28040
- Hospital Universitario Fundación Jimenez Díaz
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Málaga
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Málaga, Málaga, 스페인, 29010
- Hospital Regional Universitario Málaga Hospital Civil
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Navarre
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Pamplona, Navarre, 스페인, 31008
- Clínica Universidad de Navarra
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Pontevedra
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Vigo, Pontevedra, 스페인, 36312
- Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral
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Sevilla
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Seville, Sevilla, 스페인, 41013
- Hospital Universitario Virgen del Rocío
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Valencia
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Valencia, Valencia, 스페인, 46026
- Hospital Universitari i Politècnic La Fe
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Valladolid
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Valladolid, Valladolid, 스페인, 47003
- Hospital Clínico Universitario de Valladolid
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Zaragoza
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Zaragoza, Zaragoza, 스페인, 50009
- Hospital Clínico Universitario Lozano Bleza
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Belfast, 영국, BT9 7AB
- Belfast Health and Social Care Trust
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Harlow, 영국, CM20 1QX
- The Princess Alexandra Hospital
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London, 영국, SE1 9RT
- Guys and St Thomas NHS Foundation Trust
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Manchester, 영국, M20 4BX
- The Christie NHS Foundation Trust
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Metropolitan Borough of Wirral, 영국, CH63 4JY
- Clatterbridge Hospital
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Nottingham, 영국, NG5 1PB
- Nottingham University Hospitals NHS Trust
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Wolverhampton, 영국, WV10 0QP
- The Royal Wolverhampton NHS Trust
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-
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Salzburg, 오스트리아, A-5020
- University Hospital Salzburg
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Vienna, 오스트리아, A-1090
- Medizinische Universitaet Wien
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-
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Haifa, 이스라엘, 3109601
- Rambam Health Care Campu
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Jerusalem, 이스라엘, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, 이스라엘, 49100
- Rabin Medical Center
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Ramat Gan, 이스라엘
- The Chaim Sheba Medical Center
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Tel Aviv, 이스라엘, 6423906
- Tel Aviv Sourasky Medical Center
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-
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-
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Alessandria, 이탈리아, 15121
- A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
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Ancona, 이탈리아, 60126
- Azienda Ospedaliero Universitaria delle Marche
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Aviano, 이탈리아, 33081
- IRCCS Centro di Riferimento Oncologico
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Bologna, 이탈리아, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Oncologia medica
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Catania, 이탈리아, 95125
- Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco
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Cuneo, 이탈리아, 12100
- A.O. Santa Croce e Carle, Ospedale Carle
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Florence, 이탈리아, 50134
- AOU Careggi
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Genova, 이탈리아, 16149
- ASL 3 Genovese Oncologia Medica Villa Scassi
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Milan, 이탈리아, 20089
- IRCCS Istituto Clinico Humanitas - Cancer Center
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Naples, 이탈리아, 80138
- Universita degli Studi della Campania Luigi Vanvitelli
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Novara, 이탈리아, 28100
- Ospedale Maggiore di Novara
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Orbassano, 이탈리아, 10043
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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Padova, 이탈리아, 35128
- Oncologia Medica II Istituto Oncologico Veneto IRCCS
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Piacenza, 이탈리아, 29121
- Azienda USL di Piacenza
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Rionero in Vulture, 이탈리아, 85028
- Irccs-Crob
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Roma, 이탈리아, 00128
- Fondazione Policlinico Universitario Campus Bio-Medico
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Roma, 이탈리아, 00128
- IFO Regina Elena
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Sondrio, 이탈리아, 23100
- ASST Valtellina e Alto Lario Ospedale di Sondrio
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Varese, 이탈리아, 21100
- ASST Sette Laghi
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-
-
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Aomori
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Hirosaki, Aomori, 일본, 036-8563
- Hirosaki University Hospital
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Fukuoka
-
Fukuoka, Fukuoka, 일본, 812-8582
- Kyushu University Hospital
-
-
Hyōgo
-
Kobe, Hyōgo, 일본, 650-0047
- Kobe City Medical Center General Hospital
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-
Ishikawa-ken
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Kanazawa, Ishikawa-ken, 일본, 920-8641
- Kanazawa University Hospital
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Miyagi
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Sendai, Miyagi, 일본, 980-0873
- Sendai Kousei Hospital
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Okayama-ken
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Kurashiki, Okayama-ken, 일본, 710-8602
- Ohara HealthCare Foundation Kurashiki Central Hospital
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Osaka
-
Habikino, Osaka, 일본
- Osaka Habikino Medical Center
-
Hirakata-shi, Osaka, 일본, 573-1191
- Kansai Medical University Hospital
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Izumi, Osaka, 일본, 594-0073
- Izumi City General Hospital
-
Izumi, Osaka, 일본, 594-0073
- Kanagawa Cancer Center
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Kishiwada, Osaka, 일본, 596-8501
- Kishiwada City Hospital
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Tokyo
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Bunkyō-Ku, Tokyo, 일본
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Koto-Ku, Tokyo, 일본, 135-8550
- The Cancer Institute Hospital Of JFCR
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Shinjuku-Ku, Tokyo, 일본, 162-8655
- Center Hospital of the National Center for Global Health and Medicine
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-
-
-
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Santiago, 칠레
- Hospital Clinico Universidad de Chile
-
Santiago, 칠레
- Clinica Alemana de Santiago
-
Santiago, 칠레
- Centro de Estudios Clínicos SAGA
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Santiago, 칠레
- Clínica Santa María
-
Santiago, 칠레
- Fundación Arturo López Pérez
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Araucania
-
Temuco, Araucania, 칠레, 4780000
- James Lind Centro de Investigación del Cáncer
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Los Ríos Region
-
Valdivia, Los Ríos Region, 칠레, 5090000
- Clinical Research Chile SpA
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-
-
-
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Montreal, 캐나다, H4A 3J1
- McGill University Health Centre (MUHC)
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Toronto, 캐나다, ON M5G 2C1
- University Health Network - Princess Margaret Hospital
-
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
- Hamilton Health Sciences -Juravinski Cancer Centre
-
Newmarket, Ontario, 캐나다, L3Y 2P9
- Southlake Regional Health Centre
-
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Quebec
-
Laval, Quebec, 캐나다, H7M 3L9
- Hôpital de la Cité-de-la- Santé
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Longueuil, Quebec, 캐나다, J4V 2H1
- CISSS de la Montérégie-Centre - Hôpital Charles LeMoyne
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-
-
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Adana
-
Seyhan, Adana, 터키 (Türkiye), 01140
- Medicalpark Seyhan Hospital
-
-
Ankara
-
Çankaya, Ankara, 터키 (Türkiye), 06680
- Liv Hospital Ankara
-
-
Istanbul
-
Bağcılar, Istanbul, 터키 (Türkiye), 34214
- Bagcilar Medipol Mega University Hospital
-
Kadıköy, Istanbul, 터키 (Türkiye), 34722
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
-
Kocaeli
-
İzmit, Kocaeli, 터키 (Türkiye), 41380
- Kocaeli University Hospital
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-
-
-
-
Bialystok, 폴란드, 15-569
- II Klinika Chorob Pluc i Gruzlicy
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Gdynia, 폴란드, 81-519
- Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K
-
Lodz, 폴란드, 93-513
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii
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Lublin, 폴란드, 20-093
- Specjalistyczna Praktyka Lekarska Slawomir Mandziuka
-
Prabuty, 폴란드, 82-550
- Szpital Specjalistyczny w Prabutach Sp. z o.o
-
Rzeszów, 폴란드, 35-021
- Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p
-
Tomaszów Mazowiecki, 폴란드, 97-200
- Specjalistyczny Szpital Onkologiczny NU-MED sp. Z
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-
-
-
-
Besançon, 프랑스, 25030
- Hopital Jean Minjoz
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Boulogne-Billancourt, 프랑스, 92100
- AssAP-HP - Hopital Ambroise-Pare
-
Brest, 프랑스, 29200
- Hopital Morvan CHU de Brest
-
Caen, 프랑스, 14000
- Centre François Baclesse
-
Caen, 프랑스, 14033
- CHU de Caen - Hopital Cote de Nacre
-
Créteil, 프랑스, 94000
- Centre Hospitalier Intercommunal de Creteil (CHIC)
-
Limoges, 프랑스, 87000
- Centre Hospitalier Universitaire CHU De Limoges
-
Nantes, 프랑스, Cedex 01 44093
- CHU de Nantes
-
Paris, 프랑스, 75018
- Bichat-Claude Bernard Hospital
-
Reims, 프랑스, 51092
- CHU Reims - Hpital Maison Blanche
-
Strasbourg, 프랑스, 67091
- Hopital Civil / Nouvel Hopital Civil
-
Suresnes, 프랑스, 92150
- Hospital Foch
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Villejuif, 프랑스, 94805
- Gustave Roussy
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Debrecen, 헝가리, 4032
- Debreceni Egyetem - Klinikai Kozpont
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Farkasgyepű, 헝가리, 8582
- Veszprem Megyei Tudogyogyintezet Farkasgyepu
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Kecskemét, 헝가리, 6000
- Bacs-Kiskun County Hospital
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Szolnok, 헝가리, 5004
- Hetenyi G Korhaz, Onkologiai Kozpont
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Törökbálint, 헝가리, 2045
- Pulmonology Hospital Torokbalint
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Frenchs Forest, 호주, NSW 2086
- Northern Beaches Hospital
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Gosford, 호주, 2250
- Gosford Hospital GH - Central Coast Cancer Centre
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Heidelberg, 호주, VIC 3084
- Austin Hospital- Medical Oncology Unit
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Murdoch, 호주, WA 6150
- St John of God Murdoch Hospital
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Wollongong, 호주, NSW 2500
- Cancer Care Wollongong
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New South Wales
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Camperdown, New South Wales, 호주, 2050
- The Chris Obrien Lifehouse
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Victoria
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Ballarat Central, Victoria, 호주, 3350
- BRICC - Ballarat Health Services
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Box Hill, Victoria, 호주, 3128
- Box Hill Hospital Eastern Health Clinical School
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Voluntary written informed consent of the patient obtained before any study-specific procedure
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Age≥18 years
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Histologically or cytologically confirmed diagnosis of SCLC.
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One prior line of platinum-containing chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
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Chemotherapy-free interval (CTFI, time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) ≥ 30 days (independent of the immunotherapy maintenance, if applicable)
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Patients with history of Central Nervous System (CNS) metastases can participate provided they are pretreated and radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeated imaging (note: repeated imaging should be performed during study screening), asymptomatic, and without requirement of steroid treatment for at least 7 days before the first dose of study treatment
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Eastern Cooperative Oncology Group (ECOG) PS ≤ 2
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Adequate hematological, renal, metabolic and hepatic function:
- Hemoglobin ≥ 9.0 g/dL [patients may have received prior red blood cell (RBC) transfusion, if clinically indicated]; absolute neutrophil count (ANC) ≥ 2.0 x 10^9/L, and platelet count ≥ 100 x 10^9/L.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN.
- Albumin ≥ 3.0 g/dL.
- Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula).
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At least three weeks since last prior antineoplastic treatment and recovery to grade ≤ 1 from any adverse event (AE) related to previous anticancer treatment (excluding sensory neuropathy, immune-related hypothyroidism, anemia, asthenia and alopecia, all grade ≤ 2) according to the National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE) v.5.
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Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial irradiation (PCI), and to any other site not previously specified.
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Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to seven months after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose.
Exclusion Criteria:
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Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
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Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.).
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Active or untreated CNS metastases and/or carcinomatous meningitis.
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Patients with limited-stage disease who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization.
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Concomitant diseases/conditions:
- History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
- Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
- Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C.
- Known Gilbert's disease.
- Active uncontrolled infection. Serious non-healing wound, ulcer or bone fracture. Presence of external drainages.
- Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. Subjects taking hepatitis related antiviral therapy within six months prior to the first dose of study drugs will also be excluded.
- Intermittent or continuous oxygen requirement within two weeks prior to randomization. Patients with confirmed or suspected diagnosis of diffuse interstitial lung disease or pulmonary fibrosis.
- Patients with a second invasive malignancy treated with chemotherapy and/or RT. Patients with a previous malignancy that was completely resected with curative intention three or more years prior to randomization, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma and who has been continuously in remission since then will be permitted.
- Limitation of the patient's ability to comply with the treatment or to follow the protocol.
- Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
- Known human immunodeficiency virus (HIV) infection.
- Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or subocclusion or paralysis.
- Evident symptomatic pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
- Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g.; COVID-19 disease).
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RT in more than 35% of the bone marrow.
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History of previous bone marrow and/or stem cell transplantation and allogenic transplant.
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Patient has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of inactivated vaccines is allowed.
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Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
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History of allergy or hypersensitivity to any of the study drugs or any of their excipients.
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Women who are pregnant or breast feeding and fertile patients (men and women) who are not able to use a highly effective method of contraception
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Lurbinectedin
Patients will consecutively receive lurbinectedin on Day 1 q3wk (every three weeks = one treatment cycle) |
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
다른 이름들:
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
다른 이름들:
|
|
실험적: Lurbinectedin plus Irinotecan
Patients will consecutively receive the following q3wk (every three weeks = one treatment cycle):
|
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
다른 이름들:
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
다른 이름들:
Irinotecan 75 mg/m² intravenously Days 1 & 8 q3wk For patients aged <70 years: irinotecan 350 mg/m² intravenously Day 1 q3wk For patients aged ≥70 years: irinotecan 300 mg/m² intravenously Day 1 q3wk |
|
활성 비교기: Control arm
Best Investigator's choice prior to randomization between:
|
Irinotecan 75 mg/m² intravenously Days 1 & 8 q3wk For patients aged <70 years: irinotecan 350 mg/m² intravenously Day 1 q3wk For patients aged ≥70 years: irinotecan 300 mg/m² intravenously Day 1 q3wk Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall survival
기간: From the date of randomization to the date of death or last contact, up to 39 months
|
Overall survival (OS) will be calculated from the date of randomization to the date of death or last contact (in this case, survival will be censored on that date). |
From the date of randomization to the date of death or last contact, up to 39 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free survival by IRC (Independent Review Committee)
기간: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
|
Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease ≥ 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy. |
From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
|
|
Progression-free survival by IA (Investigator Assessment)
기간: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
|
Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease ≥ 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy. |
From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
|
|
Overall response rate by IRC
기간: From the date of randomization to the date of death or last contact, up to 39 months
|
Overall response rate (ORR) will be the percentage of patients with complete or partial response as the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. |
From the date of randomization to the date of death or last contact, up to 39 months
|
|
Overall response rate by IA
기간: From the date of randomization to the date of death or last contact, up to 39 months
|
Overall response rate (ORR) will be the percentage of patients with complete or partial response as the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. |
From the date of randomization to the date of death or last contact, up to 39 months
|
|
Overall survival rate at 12 months
기간: At 12 months
|
Overall survival rate at 12 months is defined as the percentage of people who are still alive at 12 months after randomization. |
At 12 months
|
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Overall survival rate at 24 months
기간: At 24 months
|
Overall survival rate at 24 months is defined as the percentage of people who are still alive at 24 months after randomization. |
At 24 months
|
|
Progression-free survival rate at 6 months by IRC
기간: At 6 months
|
Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization |
At 6 months
|
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Progression-free survival rate at 6 months by IA
기간: At 6 months
|
Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization |
At 6 months
|
|
Progression-free survival rate at 12 months by IRC
기간: At 12 months
|
Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization |
At 12 months
|
|
Progression-free survival rate at 12 months by IA
기간: At 12 months
|
Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization |
At 12 months
|
|
Duration of response by IRC
기간: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
|
Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. |
From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
|
|
Duration of response by IA
기간: From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
|
Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease ≥ 20%, stable disease when the change is > -30% and ≤ 20%, partial response when there is a decrease in sum of target disease ≥ 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. |
From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
|
|
Patient-reported outcomes
기간: At baseline and every six weeks (± one week) until end of treatment, up to 39 months
|
To measure the quality of life of patients, the Lung Cancer Symptom Scale (LCSS) questionnaire will be analyzed. |
At baseline and every six weeks (± one week) until end of treatment, up to 39 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PM1183-C-008-21
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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