Spots Global Cancer Trial Database for Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
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Trial Identification
Brief Title: Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
Official Title: A Two-part, Open-label, Randomized, Phase 2/3 Study of Dinutuximab and Irinotecan Versus Irinotecan for Second Line Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Study ID: NCT03098030
Conditions
Study Description
Brief Summary: This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period \<3 months or ≥3 months).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Clinical Research Center, Anchorage, Alaska, United States
Cancer Treatment Centers of America - Western Regional Medical Center, Goodyear, Arizona, United States
Innovative Clinical Research Institute, Tucson, Arizona, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
VA Palo Alto Health Care System, Palo Alto, California, United States
Olive View - UCLA, Sylmar, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
Hartford Hospital, Hartford, Connecticut, United States
Eastern Connecticut Hematology and Oncology Assoc, Norwich, Connecticut, United States
Alpha Oncology Research LLC, DeBary, Florida, United States
21st Century Oncology, Jacksonville, Florida, United States
Comprehensive Hematology Oncology, Saint Petersburg, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, P.C., Marietta, Georgia, United States
Baptist Health Floyd Cancer Center, New Albany, Indiana, United States
Physicians' Clinic of Iowa Hematology and Oncology, Cedar Rapids, Iowa, United States
Kentucky Cancer Clinic, Hazard, Kentucky, United States
University of Kentucky, Lexington, Kentucky, United States
21st Century Oncology, Louisville, Kentucky, United States
Cox Health Medical, Springfield, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
The University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States
UH Cleveland Medical Center, Cleveland, Ohio, United States
Cancer Treatment Centers of America at Southwestern RMC, Tulsa, Oklahoma, United States
Kaiser Permanente Northwest Center for Health Research CRSS, Portland, Oregon, United States
Fox Chase Cancer Center Office of Clinical Research, Philadelphia, Pennsylvania, United States
Cancer Treatment Centers of America at Eastern Regional Medical Center, Philadelphia, Pennsylvania, United States
Charleston Oncology, Charleston, South Carolina, United States
Spartanburg Medical Center/Gibbs Cancer Center and Research Institute, Spartanburg, South Carolina, United States
Prairie Lakes Health Care, Watertown, South Dakota, United States
Center for Biomedical Research, Knoxville, Tennessee, United States
Texas Health Physicians Group, Arlington, Texas, United States
Plano Cancer Institute, Plano, Texas, United States
The University of Texas Health Science Center at Tyler, Office of Clinical Studies, Tyler, Texas, United States
Vista Oncology (Shelton office), Shelton, Washington, United States
United Hospital Center, Bridgeport, West Virginia, United States
Camden Clark Medical Center / Regional Cancer Center, Parkersburg, West Virginia, United States
University of Wisoncsin - Carbone Cancer Ctr, Madison, Wisconsin, United States
Mid North Coast Cancer Institute Coff Habour Health Campus, Coffs Harbour, New South Wales, Australia
Mater Misericordiae Limited and Mater Medical Research Institute Limited, South Brisbane, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Ballarat Health Services, Ballarat, Victoria, Australia
Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad, Blagoevgrad, , Bulgaria
Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas, Burgas, , Bulgaria
Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich, Dobrich, , Bulgaria
Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo, Gabrovo, , Bulgaria
Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte, Panagyurishte, , Bulgaria
Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven, Pleven, , Bulgaria
Clinic of Oncology, UMHAT Pulmed, Plovdiv, , Bulgaria
First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD, Plovdiv, , Bulgaria
First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia, Sofia, , Bulgaria
Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia, Sofia, , Bulgaria
Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia, Sofia, , Bulgaria
Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia, Sofia, , Bulgaria
Clinic of Oncology, UMHAT SofiaMed, Sofia, , Bulgaria
Clinic of Oncology, MHAT Sveta Marina, Varna, , Bulgaria
Cross Cancer Institute - Clinical Trials Unit, Edmonton, Alberta, Canada
Horizon Health Network - The Moncton Hosoital, Moncton, New Brunswick, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Windsor Regional Hospital Cancer Program, Windsor, Ontario, Canada
McGill University Health Center, Montréal, Quebec, Canada
L'Institut Universitaire de Cardiologie et de pneumologie de Quebec, Québec, Quebec, Canada
Hopital Nord, Marseille, Alpes-Côte d'Azur, France
Institut Regional du Cancer de Montpellier, Montpellier, Occitanie, France
Institut de Cancérologie de l'Ouest - Centre Paul Papin, Angers, Pays De La Loire, France
Clinique Victor Hugo, Le Mans, Pays De La Loire, France
URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse, Bron, Rhône-Alpes, France
URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse, Lyon, Rhône-Alpes, France
Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud, Pierre Bénite, Rhône-Alpes, France
CHU Brest, Brest, , France
Centre François Baclesse, Caen, , France
CHI Créteil, Créteil, , France
Institut Paoli-Calmettes, Service Dòncologie Médicale, Marseille, , France
Institut de Cancérologie de l'Ouest - Centre René Gauducheau, Saint-Herblain, , France
Centre Paul Strauss, Strasbourg, , France
Nouvel Hôpital Civil de Strasbourg, Strasbourg, , France
LTD High Technology Hospital Medcenter, Batumi, , Georgia
LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine'', Tbilisi, , Georgia
High Technology Medical Center, University Clinic, Tbilisi, , Georgia
Institute of Clinical Oncology, Tbilisi, , Georgia
Multiprofile Clinic Consillium Medulla, Tbilisi, , Georgia
Princess Margaret Hospital, Kowloon, , Hong Kong
Queen Elizabeth Hospital, Kowloon, , Hong Kong
Queen Mary Hospital, Pokfulam, , Hong Kong
Hetenyi Geza Hospital, Szolnok, Jasz-Nagykun-Szolnok, Hungary
Koranyi National Institute of Pulmonology - Horváth, Budapest, , Hungary
Koranyi National Institute of TBC and Pulmonology, Budapest, , Hungary
Korányi National Institute, Budapest, , Hungary
Semmelweis Egyetem AOK Pulmonologiai Klinika, Budapest, , Hungary
Veszprém Megyei Tüdőgyógyintézet, Farkasgyepű, , Hungary
Matrai Gyogyintezet, Matrahaza, , Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály, Miskolc, , Hungary
Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza, Tatabanya, , Hungary
Tudogyogyintezet Torokbalint, Torokbalint, , Hungary
Zala Megyei Szent Rafael Korhaz, Zalaegerszeg, , Hungary
Sri Venkateshwara Hospitals, Bangalore, Karnataka, India
KLES Dr Prabhakar Kore Hospital & MRC, Nehru Nagar, Karnataka, India
Jaslok Hospital & Research Center, Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital, Pune, Maharashtra, India
Grant Medical Foundation Ruby Hall Clinic, Pune, Maharashtra, India
Birla Cancer Centre, SMS Hospital, Jaipur, Rajasthan, India
Healthcare Global (HCG) Towers, Bangalore, , India
Bhagawan Mahaveer Cancer Hospital, Jaipur, , India
Dipartimento di Oncologia, ARNAS Garibaldi, Catania, , Italy
Istituto Nazionale dei Tumori, Milan, , Italy
Istituto Europeo di Oncologia (IEO), Milano, Milan, , Italy
Ospedale Santa Maria della Misericordia, Perugia, Perugia, , Italy
Radiation Oncology, Campus Bio-Medico University, Rome, , Italy
Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena, Siena, , Italy
A.O.U. San Luigi Gonzaga, Orbassano (Torino), Torino, , Italy
Kosin University Gospel Hospital, Busan, , Korea, Republic of
Chungbuk National University Hospital, Chungcheongbuk-do, , Korea, Republic of
Kyungpook National University Medical Center, Daegu, , Korea, Republic of
Kyungpook University Chilgok Hospital, Daegu, , Korea, Republic of
Keimyung University Dongsan Medical Centre, Daegu, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
CHA Bundang Medical Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Pusan National University Yangsan Hospital, Gyeongsangnam-do, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeonnam, , Korea, Republic of
Gachon Universtiy Gil Medical Center, Namdong, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Boramae Medical Center, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Wonju Severance Christian Hospital, Wonju-Si, Gangwon-do, , Korea, Republic of
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos, Kaunas, , Lithuania
National Cancer Institute, Vilnius, , Lithuania
Vilnius University Hospital Santaros Klinikos, Vilnius, , Lithuania
Hospital Kuala Lumpur, Kuala Lumpur, , Malaysia
Department of Medicine, Faculty of Medicine, Kuala Lumpur, , Malaysia
Hospital Umum Sarawak, Kuching, , Malaysia
National Cancer Institute, Putrajaya, , Malaysia
Cebu Doctors University Hospital, Cebu City, , Philippines
Davao Doctors Hospital, Davao City, , Philippines
Manila Doctors Hospital, Manila, , Philippines
St. Luke's Medical Center - Quezon City, Quezon City, , Philippines
St. Luke's Medical Centre, Quezon City, , Philippines
Szpital Specjalistyczny w Prabutach Sp. z o.o, Prabuty, Pomeranian Voivodeship, Poland
Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie, Olsztyn, Warminsko-Mazurskie, Poland
Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina, Mrozy, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock, , Poland
Szpital Chorób Płuc im Św. Józefa w Pilchowicach, Pilchowice, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów, Poznań, , Poland
Centrum Onkologii-Instytut im. Sklodowskiej-Curie, Warszawa, , Poland
Wojskowy Instytut Medyczny, Warszawa, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna, Łódź, Łódź Voivodeship, Poland
Oncopremium Team LTD, Baia-Mare, , Romania
Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca, Cluj-Napoca, , Romania
Medisprof LTD, Cluj-Napoca, , Romania
SC Oncolab LTD, Craiova, , Romania
SC Oncology Center Sf. Nectarie LTD, Craiova, , Romania
Emergency County Hospital Satu-Mare, Medical Oncology Clinic, Satu-Mare, , Romania
Emergency Hospital ,Sf. Ioan cel Nou', Suceava, , Romania
Oncocenter Oncology Clinic LTD, Timisoara, , Romania
State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary, Arkhangelsk, , Russian Federation
State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary, Ekaterinburg, , Russian Federation
Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region, Kursk, , Russian Federation
Federal State Budgetary Institution, Natiоnal Medical Research Center of Oncology n.a. N.N. Blokhin of Ministry of Healthcare of the Russian Federation, Moscow, , Russian Federation
State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department, Moscow, , Russian Federation
State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary", Moscow, , Russian Federation
State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1, Novosibirsk, , Russian Federation
State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary, Novosibirsk, , Russian Federation
Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary, Omsk, , Russian Federation
State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary, Orenburg, , Russian Federation
Center of Palliative Care-Devita LLC, Saint Petersburg, , Russian Federation
State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital, Saint-Petersburg, , Russian Federation
BioEq, LLC, Saint-Petersburg, , Russian Federation
Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov, Saint-Petersburg, , Russian Federation
State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological), Saint-Petersburg, , Russian Federation
Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary, Saint-Petersburg, , Russian Federation
State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary, Samara, , Russian Federation
State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital, Yaroslavl, , Russian Federation
St. Jacob´s Hospital Bardejov - Department of Clinical Oncology, Bardejov, , Slovakia
Faculty Hospital Zilina, Žilina, , Slovakia
Hospital General Universitario de Elche, Elche, Alicante, Spain
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
CHU A Coruña, Coruña, Galicia, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
Hospital General de Alicante, Alicante, , Spain
Hospital Quirón Dexeus, Barcelona, , Spain
Hospital Universitari Vall d´Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofia, Córdoba, , Spain
Instituto Catalán de Oncología (ICO) - Josep Trueta, Girona, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital General Universitário Gregorio Marañón, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Madrid Norte Sanchinarro, Madrid, , Spain
H. M. Puerta del Sur (H. Móstoles), Madrid, , Spain
Hospital Regional de Málaga (H. Carlos Haya), Málaga, , Spain
Complexo Hospitalario Universitario de Ourense (CHUO), Ourense, , Spain
Hospital Virgen de los Lirios Alcoy, Planta, , Spain
Corporació Sanitària Parc Taulí, Sabadell, , Spain
Hospital Universitario Virgen de Valme, Sevilla, , Spain
Hospital Universitario y Politécnico de La Fe, Valencia, , Spain
Hospital Álvaro Cunqueiro, Vigo, , Spain
Hospital Lozano Blesa, Zaragoza, , Spain
E-Da Hospital, Kaohsiung City, , Taiwan
E-Da Hospital, Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital, Taichung City, , Taiwan
Chi Mei Hospital, Liouying, Tainan City, , Taiwan
Chang-Gung Memorial Hospital, Linkou, Taoyuan City, , Taiwan
King Chulalongkorn Memorial Hospital, Bangkok, , Thailand
National Cancer Institute of Thailand, Bangkok, , Thailand
Siriraj Hopsital, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, , Thailand
Srinagarind Hospital, Khon Kaen, , Thailand
Naresuan University Hospital, Phitsanulok, , Thailand
Songklanagarind Hospital, Songkhla, , Thailand
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council," Municipal Institution "Multifield Dnipropetrovsk City Hospital #4" of Dnipropetrovsk Regional Council, Department of Chemotherapy, Dnipro, Dnipropetrovsk, Ukraine
Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre, Uzhgorod, Zakarpattia, Ukraine
Regional Communal Nonprofit Enterprise, Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary, Surgery Department, State Higher Educational Establishment of Ukraine, Bukovinian State Medical University, Department of Onc and Radiology, Chernivtsi, , Ukraine
Communal Non-profit Enterprise "Kyiv City Clinical Oncology Center" of Executive body of Kyiv City Council, Kyiv City Clinical Oncology Center by Main Department of Health Protection Kyiv, Hospital of Day Stay for Oncology Patients, Kiev, , Ukraine
Municipal Nonprofit Institution "Odessa Regional Oncology Dispensary" of Odessa Regional Council, Municipal Institution Odesa Regional Oncology Dispensary, Hospital of Day Stay (Unit of Dispensary-Polyclinic Department), Odessa, , Ukraine
Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy, Vinnitsya, , Ukraine
Princess Alexandra Hospital, Harlow, Essex, United Kingdom
Royal Marsden Hospital, Chelsea, London, United Kingdom
St James' Institute of Oncology, Leeds, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust, London, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
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