Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

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

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).

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Biological: Dinutuximab; Drug: Irinotecan; Drug: Topotecan

• Study Type: Interventional
• Enrollment (Actual): 483
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, NSW 2450
      • Mid North Coast Cancer Institute Coff Habour Health Campus
  • Queensland
    • South Brisbane, Queensland, Australia, QLD 4101
      • Mater Misericordiae Limited and Mater Medical Research Institute Limited
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Ballarat Health Services
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad
  • Burgas, Bulgaria, 8000
    • Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas
  • Dobrich, Bulgaria, 9300
    • Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich
  • Gabrovo, Bulgaria, 5300
    • Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo
  • Panagyurishte, Bulgaria, 4500
    • Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte
  • Pleven, Bulgaria, 5800
    • Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven
  • Plovdiv, Bulgaria, 4001
    • Clinic of Oncology, UMHAT Pulmed
  • Plovdiv, Bulgaria, 4004
    • First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD
  • Sofia, Bulgaria, 1303
    • First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia
  • Sofia, Bulgaria, 1330
    • Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia
  • Sofia, Bulgaria, 1431
    • Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia
  • Sofia, Bulgaria, 1756
    • Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia
  • Sofia, Bulgaria, 1797
    • Clinic of Oncology, UMHAT SofiaMed
  • Varna, Bulgaria, 9010
    • Clinic of Oncology, MHAT Sveta Marina
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute - Clinical Trials Unit
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Horizon Health Network - The Moncton Hosoital
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
    • Windsor, Ontario, Canada, N8W 2X3
      • Windsor Regional Hospital Cancer Program
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Center
    • Québec, Quebec, Canada, G1V 4G5
      • l'Institut universitaire de cardiologie et de pneumologie de Québec
• France
  • Brest, France, 29609
    • CHU Brest
  • Caen, France, 14000
    • Centre Francois Baclesse
  • Créteil, France, 94010
    • CHi Creteil
  • Marseille, France, 13009
    • Institut Paoli-Calmettes, Service Dòncologie Médicale
  • Saint-Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
  • Strasbourg, France, 67091
    • Nouvel Hôpital Civil de Strasbourg
  • Strasbourg, France, 67065
    • Centre Paul Strauss
  • Alpes-Côte d'Azur
    • Marseille, Alpes-Côte d'Azur, France, 13915
      • Hôpital Nord
  • Occitanie
    • Montpellier, Occitanie, France, 34298
      • Institut Régional du Cancer de Montpellier
  • Pays De La Loire
    • Angers, Pays De La Loire, France, 49055
      • Institut de Cancérologie de l'Ouest - Centre Paul Papin
    • Le Mans, Pays De La Loire, France, 72000
      • Clinique Victor Hugo
  • Rhône-Alpes
    • Bron, Rhône-Alpes, France, 69677
      • URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
    • Lyon, Rhône-Alpes, France, 69004
      • URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
    • Pierre Bénite, Rhône-Alpes, France, 69945
      • Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud
• Georgia
  • Batumi, Georgia, 6000
    • LTD High Technology Hospital Medcenter
  • Tbilisi, Georgia, 0144
    • High Technology Medical Center, University Clinic
  • Tbilisi, Georgia, 0112
    • LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''
  • Tbilisi, Georgia, 0159
    • Institute of Clinical Oncology
  • Tbilisi, Georgia, 0186
    • Multiprofile Clinic Consillium Medulla
• Hong Kong
  • Kowloon, Hong Kong
    • Princess Margaret Hospital
  • Kowloon, Hong Kong
    • Queen Elizabeth Hospital
  • Pokfulam, Hong Kong
    • Queen Mary Hospital
• Hungary
  • Budapest, Hungary, 1121
    • Koranyi National Institute of Pulmonology - Horváth
  • Budapest, Hungary, 1121
    • Koranyi National Institute of TBC and Pulmonology
  • Budapest, Hungary, 1121
    • Korányi National Institute
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem AOK Pulmonologiai Klinika
  • Farkasgyepű, Hungary, 8582
    • Veszprém Megyei Tudőgyógyintézet
  • Matrahaza, Hungary, 3233
    • Matrai Gyogyintezet
  • Miskolc, Hungary, 3529
    • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály
  • Tatabanya, Hungary, 2800
    • Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza
  • Torokbalint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Szent Rafael Korhaz
  • Jasz-Nagykun-Szolnok
    • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5004
      • Hetenyi Geza Hospital
• India
  • Bangalore, India, 560020
    • Healthcare Global (HCG) Towers
  • Jaipur, India, 302017
    • Bhagawan Mahaveer Cancer Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560076
      • Sri Venkateshwara Hospitals
    • Nehru Nagar, Karnataka, India, 590010
      • KLEs Dr Prabhakar Kore Hospital & MRC
  • Maharashtra
    • Mumbai, Maharashtra, India, 400026
      • Jaslok Hospital & Research Center
    • Pune, Maharashtra, India, 411001
      • Deenanath Mangeshkar Hospital
    • Pune, Maharashtra, India, 411001
      • Grant Medical foundation Ruby Hall Clinic
  • Rajasthan
    • Jaipur, Rajasthan, India, 302004
      • Birla Cancer Centre, SMS Hospital
• Italy
  • Catania, Italy, 95122
    • Dipartimento di Oncologia, ARNAS Garibaldi
  • Milan, Italy, 20123
    • Istituto Nazionale dei Tumori
  • Milan, Italy
    • Istituto Europeo di Oncologia (IEO), Milano
  • Perugia, Italy
    • Ospedale Santa Maria della Misericordia, Perugia
  • Rome, Italy, I-00128
    • Radiation Oncology, Campus Bio-Medico University
  • Siena, Italy, I-53100
    • Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena
  • Torino, Italy
    • A.O.U. San Luigi Gonzaga, Orbassano (Torino)
• Korea, Republic of
  • Busan, Korea, Republic of, 49267
    • Kosin University Gospel Hospital
  • Chungcheongbuk-do, Korea, Republic of, 28644
    • Chungbuk National University Hospital
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Medical Center
  • Daegu, Korea, Republic of, 41404
    • Kyungpook University Chilgok Hospital
  • Daegu, Korea, Republic of, 42601
    • Keimyung University Dongsan Medical Centre
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, Korea, Republic of, 13496
    • CHA Bundang Medical Center
  • Gyeongsangnam-do, Korea, Republic of, 50612
    • Pusan National University Yangsan Hospital
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Jeonnam, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
  • Namdong, Korea, Republic of
    • Gachon Universtiy Gil Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 07061
    • Seoul National University Boramae Medical Center
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital
  • Wonju-Si, Gangwon-do, Korea, Republic of, 26426
    • WonJu Severance Christian Hospital
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
  • Vilnius, Lithuania, 08660
    • National Cancer Institute
  • Vilnius, Lithuania, 08661
    • Vilnius University hospital Santaros klinikos
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kuala Lumpur, Malaysia
    • Department of Medicine, Faculty of Medicine
  • Kuching, Malaysia, 93586
    • Hospital Umum Sarawak
  • Putrajaya, Malaysia, 62250
    • National Cancer Institute
• Philippines
  • Cebu City, Philippines, 6000
    • Cebu Doctors University Hospital
  • Davao City, Philippines, 8000
    • Davao Doctors Hospital
  • Manila, Philippines, 1000
    • Manila Doctors Hospital
  • Quezon City, Philippines, 1102
    • St. Luke's Medical Center - Quezon City
  • Quezon City, Philippines, 1102
    • St. Luke's Medical Centre
• Poland
  • Mrozy, Poland, 05-320
    • Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Pilchowice, Poland, 44-145
    • Szpital Chorób Płuc im Św. Józefa w Pilchowicach
  • Poznań, Poland, 60-569
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny
  • Warszawa, Poland, 02-781
    • Centrum Onkologii-Instytut im. Sklodowskiej-Curie
  • Pomeranian Voivodeship
    • Prabuty, Pomeranian Voivodeship, Poland, 82-550
      • Szpital Specjalistyczny w Prabutach Sp. z o.o
  • Warminsko-Mazurskie
    • Olsztyn, Warminsko-Mazurskie, Poland, 10-357
      • Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie
  • Łódź Voivodeship
    • Łódź, Łódź Voivodeship, Poland, 90-242
      • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo-Akcyjna
• Romania
  • Baia-Mare, Romania, 430291
    • Oncopremium Team LTD
  • Cluj-Napoca, Romania, 400015
    • Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca
  • Cluj-Napoca, Romania, 400058
    • Medisprof LTD
  • Craiova, Romania, 200385
    • SC Oncolab LTD
  • Craiova, Romania
    • SC Oncology Center Sf. Nectarie LTD
  • Satu-Mare, Romania, 440055
    • Emergency County Hospital Satu-Mare, Medical Oncology Clinic
  • Suceava, Romania, 720224
    • Emergency Hospital ,Sf. Ioan cel Nou'
  • Timisoara, Romania, 300166
    • Oncocenter Oncology Clinic LTD
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary
  • Ekaterinburg, Russian Federation, 620036
    • State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary
  • Kursk, Russian Federation, 305524
    • Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region
  • Moscow, Russian Federation, 115478
    • 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, 143423
    • 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"
  • Novosibirsk, Russian Federation, 630047
    • State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1
  • Novosibirsk, Russian Federation, 630108
    • State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary
  • Omsk, Russian Federation, 644013
    • Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary
  • Orenburg, Russian Federation, 460021
    • State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary
  • Saint Petersburg, Russian Federation, 197183
    • Center of Palliative Care-Devita LLC
  • Saint-Petersburg, Russian Federation, 194291
    • State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital
  • Saint-Petersburg, Russian Federation, 197342
    • BioEq, LLC
  • Saint-Petersburg, Russian Federation, 197758
    • Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov
  • Saint-Petersburg, Russian Federation, 197758
    • State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological)
  • Saint-Petersburg, Russian Federation, 198255
    • Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
  • Samara, Russian Federation, 443031
    • State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary
  • Yaroslavl, Russian Federation, 150054
    • State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital
• Slovakia
  • Bardejov, Slovakia, 08501
    • St. Jacob´s Hospital Bardejov - Department of Clinical Oncology
  • Žilina, Slovakia, 012 07
    • Faculty Hospital Zilina
• Spain
  • Alicante, Spain, 03010
    • Hospital General de Alicante
  • Barcelona, Spain, 08028
    • Hospital Quiron Dexeus
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d´Hebrón
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Girona, Spain, 17007
    • Instituto Catalán de Oncología (ICO) - Josep Trueta
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28050
    • Hospital Universitario Madrid Norte Sanchinarro
  • Madrid, Spain, 28938
    • H. M. Puerta del Sur (H. Móstoles)
  • Málaga, Spain, 29006
    • Hospital Regional de Málaga (H. Carlos Haya)
  • Ourense, Spain, 32005
    • Complexo Hospitalario Universitario de Ourense (CHUO)
  • Planta, Spain, 03804
    • Hospital Virgen de los Lirios Alcoy
  • Sabadell, Spain, 08208
    • Corporacio Sanitaria Parc Tauli
  • Sevilla, Spain, 41014
    • Hospital Universitario Virgen de Valme
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico de la Fe
  • Vigo, Spain, 36312
    • Hospital Álvaro Cunqueiro
  • Zaragoza, Spain, 50009
    • Hospital Lozano Blesa
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • Galicia
    • Coruña, Galicia, Spain, 15006
      • CHU A Coruña
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung City, Taiwan, 82445
    • E-Da Hospital
  • Kaohsiung City, Taiwan, 42445
    • E-Da Hospital
  • Taichung City, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Tainan City, Taiwan, 736
    • Chi Mei Hospital, Liouying
  • Taoyuan City, Taiwan, 33305
    • Chang-Gung Memorial Hospital, Linkou
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • National Cancer Institute of Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hopsital
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
  • Phitsanulok, Thailand, 65000
    • Naresuan University Hospital
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58013
    • 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
  • Kiev, Ukraine, 03115
    • 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
  • Odessa, Ukraine, 65055
    • 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)
  • Vinnitsya, Ukraine, 21029
    • Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy
  • Dnipropetrovsk
    • Dnipro, Dnipropetrovsk, Ukraine, 49102
      • 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
  • Zakarpattia
    • Uzhgorod, Zakarpattia, Ukraine, 88000
      • Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • St James' Institute of Oncology
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew's Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
  • Essex
    • Harlow, Essex, United Kingdom, CM20 1QX
      • Princess Alexandra Hospital
  • London
    • Chelsea, London, United Kingdom, SW3 6JJ
      • Royal Marsden Hospital
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Clinical Research Center
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Cancer Treatment Centers of America - Western Regional Medical Center
    • Tucson, Arizona, United States, 85745
      • Innovative Clinical Research Institute
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System
    • Sylmar, California, United States, 91342
      • Olive View - UCLA
    • Whittier, California, United States, 90603
      • Innovative Clinical Research Institute
  • Connecticut
    • Hartford, Connecticut, United States, 06062
      • Hartford Hospital
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology and Oncology Assoc
  • Florida
    • DeBary, Florida, United States, 32713
      • Alpha Oncology Research LLC
    • Jacksonville, Florida, United States, 32204
      • 21st Century Oncology
    • Saint Petersburg, Florida, United States, 33709
      • Comprehensive Hematology Oncology
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, P.C.
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Baptist Health Floyd Cancer Center
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Physicians' Clinic of Iowa Hematology and Oncology
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Kentucky Cancer Clinic
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
    • Louisville, Kentucky, United States, 40215
      • 21st Century Oncology
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Cox Health Medical
  • Montana
    • Billings, Montana, United States, 59102
      • St. Vincent Frontier Cancer Center
    • Billings, Montana, United States, 59101
      • Billings Clinic Cancer Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • The University of New Mexico Comprehensive Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UH Cleveland Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Cancer Treatment Centers of America at Southwestern RMC
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Northwest Center for Health Research CRSS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center Office of Clinical Research
    • Philadelphia, Pennsylvania, United States, 19124
      • Cancer Treatment Centers of America at Eastern Regional Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Oncology
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center/Gibbs Cancer Center and Research Institute
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Prairie Lakes Health Care
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Center for Biomedical Research
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Health Physicians Group
    • Plano, Texas, United States, 75093
      • Plano Cancer Institute
    • Tyler, Texas, United States, 75701
      • The University of Texas Health Science Center at Tyler, Office of Clinical Studies
  • Washington
    • Shelton, Washington, United States, 98584
      • Vista Oncology (Shelton office)
  • West Virginia
    • Bridgeport, West Virginia, United States, 26330
      • United Hospital Center
    • Parkersburg, West Virginia, United States, 26101
      • Camden Clark Medical Center / Regional Cancer Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisoncsin - Carbone Cancer Ctr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin).
2. Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible).
3. Have no curative therapy available.
4. Have a life expectancy of at least 12 weeks.
5. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Have adequate bone marrow and hepatic function.
7. Have calculated creatinine clearance (CrCL) ≥30 mL/minute or serum creatinine ≤1.5 times below the upper limit of normal.
8. Women of reproductive potential must not be pregnant or breastfeeding and have a negative urine or serum pregnancy test obtained within 7 days prior to the first dose of study treatment.
9. Subjects must agree to consistently use 2 forms of highly effective contraception/birth control between signing of the informed consent and 60 days after the last study drug administration.

Exclusion Criteria:

1. Candidate for re-treatment with original platinum-based regimen as second-line therapy.
2. Prior treatment with irinotecan, topotecan, or dinutuximab.
3. Have active brain metastases. Subjects with brain metastases are allowed if they completed definitive brain therapy, are asymptomatic and radiologically stable, and if they are not currently receiving corticosteroids or radiation.
4. Have mixed small cell and non-small cell histologic features.
5. Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated <3 years ago.
6. Have a history or current evidence of uncontrolled cardiovascular disease.
7. Have not recovered from prior surgery, significant trauma, systemic anticancer therapy, radiation therapy or investigational therapy to Grade 1 or better toxicity prior to enrollment (Part 1) or randomization (Part 2).
8. Have had organ allograft or hematopoietic transplantation.
9. Known to be human immunodeficiency virus (HIV) positive.
10. Have an active infection requiring treatment or one that is clinically serious in the Investigator's opinion.
11. Have received a live vaccine within 6 months of enrollment (Part 1) or randomization (Part 2).
12. Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization (Part 2).
13. Have any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subject's compliance in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dinutuximab + Irinotecan; Dinutuximab (10 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.	Biological: Dinutuximab; Dinutuximab injection, for intravenous (IV) use; Other Names: Unituxin®; ch14.18; Drug: Irinotecan; Irinotecan injection, IV infusion; Other Names: Camptosar®
Active Comparator: Part 2: Irinotecan; Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle.	Drug: Irinotecan; Irinotecan injection, IV infusion; Other Names: Camptosar®
Experimental: Part 2: Dinutuximab + Irinotecan; Dinutuximab (16 mg/m^2 IV) + Irinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m^2 increments per cycle if maximal pain is <Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m^2 IV.	Biological: Dinutuximab; Dinutuximab injection, for intravenous (IV) use; Other Names: Unituxin®; ch14.18; Drug: Irinotecan; Irinotecan injection, IV infusion; Other Names: Camptosar®
Active Comparator: Part 2: Topotecan; Topotecan (1.5 mg/m^2 IV) on Days 1 to 5 of each q21d cycle.	Drug: Topotecan; Topotecan for injection; Other Names: Hycamtin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS will be derived as: (date of death - date of randomization) + 1. Subjects who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the subject was known to be alive.	Up to approximately 2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS will be defined as the time from the date of randomization to the date of first documentation of tumor progression or death from any cause, whichever occurs first.	Up to approximately 2.5 years
Objective Response Rate (ORR)	The ORR is the percentage of subjects with best overall response of either complete response (CR) or partial response (PR); ORR = CR + PR. Per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters as confirmed by CT or MRI.	Up to approximately 2.5 years
Clinical Benefit Rate (CBR)	The CBR is defined as the percentage of subjects with either a CR, PR, or stable disease (SD), relative to the number of subjects in the treatment group. Per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study, as confirmed by CT or MRI .	Up to approximately 2.5 years

Collaborators and Investigators

• Sponsor: United Therapeutics

Publications and helpful links

General Publications

• Edelman MJ, Dvorkin M, Laktionov K, Navarro A, Juan-Vidal O, Kozlov V, Golden G, Jordan O, Deng CQ, Bentsion D, Chouaid C, Dechev H, Dowlati A, Fernández Núñez N, Ivashchuk O, Kiladze I, Kortua T, Leighl N, Luft A, Makharadze T, Min Y, Quantin X; DISTINCT study investigators. Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer. Lung Cancer. 2022 Apr;166:135-142. doi: 10.1016/j.lungcan.2022.03.003. Epub 2022 Mar 4.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 27, 2020
• Study Completion (Actual): March 26, 2020

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Topotecan; Irinotecan; Dinutuximab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan; Topotecan; Dinutuximab
• Other Study ID Numbers: DIV-SCLC-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No