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
1 other identifier
interventional
483
23 countries
226
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2017
Typical duration for phase_2
226 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2017
CompletedFirst Posted
Study publicly available on registry
March 31, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2020
CompletedResults Posted
Study results publicly available
December 9, 2020
CompletedDecember 9, 2020
November 1, 2020
2.7 years
March 22, 2017
October 7, 2020
November 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Progression-free Survival (PFS)
Up to approximately 2.5 years
Objective Response Rate (ORR)
Up to approximately 2.5 years
Clinical Benefit Rate (CBR)
Up to approximately 2.5 years
Study Arms (4)
Part 1: Dinutuximab + Irinotecan
EXPERIMENTALDinutuximab (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.
Part 2: Irinotecan
ACTIVE COMPARATORIrinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle.
Part 2: Dinutuximab + Irinotecan
EXPERIMENTALDinutuximab (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.
Part 2: Topotecan
ACTIVE COMPARATORTopotecan (1.5 mg/m\^2 IV) on Days 1 to 5 of each q21d cycle.
Interventions
Dinutuximab injection, for intravenous (IV) use
Irinotecan injection, IV infusion
Eligibility Criteria
You may qualify if:
- Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin).
- Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible).
- Have no curative therapy available.
- Have a life expectancy of at least 12 weeks.
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have adequate bone marrow and hepatic function.
- Have calculated creatinine clearance (CrCL) ≥30 mL/minute or serum creatinine ≤1.5 times below the upper limit of normal.
- 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.
- 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.
You may not qualify if:
- Candidate for re-treatment with original platinum-based regimen as second-line therapy.
- Prior treatment with irinotecan, topotecan, or dinutuximab.
- 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.
- Have mixed small cell and non-small cell histologic features.
- 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.
- Have a history or current evidence of uncontrolled cardiovascular disease.
- 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).
- Have had organ allograft or hematopoietic transplantation.
- Known to be human immunodeficiency virus (HIV) positive.
- Have an active infection requiring treatment or one that is clinically serious in the Investigator's opinion.
- Have received a live vaccine within 6 months of enrollment (Part 1) or randomization (Part 2).
- Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization (Part 2).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (226)
Alaska Clinical Research Center
Anchorage, Alaska, 99503, United States
Cancer Treatment Centers of America - Western Regional Medical Center
Goodyear, Arizona, 85338, United States
Innovative Clinical Research Institute
Tucson, Arizona, 85745, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Olive View - UCLA
Sylmar, California, 91342, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Hartford Hospital
Hartford, Connecticut, 06062, United States
Eastern Connecticut Hematology and Oncology Assoc
Norwich, Connecticut, 06360, United States
Alpha Oncology Research LLC
DeBary, Florida, 32713, United States
21st Century Oncology
Jacksonville, Florida, 32204, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060, United States
Baptist Health Floyd Cancer Center
New Albany, Indiana, 47150, United States
Physicians' Clinic of Iowa Hematology and Oncology
Cedar Rapids, Iowa, 52403, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
21st Century Oncology
Louisville, Kentucky, 40215, United States
Cox Health Medical
Springfield, Missouri, 65807, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
St. Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
The University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131, United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cancer Treatment Centers of America at Southwestern RMC
Tulsa, Oklahoma, 74133, United States
Kaiser Permanente Northwest Center for Health Research CRSS
Portland, Oregon, 97227, United States
Fox Chase Cancer Center Office of Clinical Research
Philadelphia, Pennsylvania, 19111, United States
Cancer Treatment Centers of America at Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124, United States
Charleston Oncology
Charleston, South Carolina, 29414, United States
Spartanburg Medical Center/Gibbs Cancer Center and Research Institute
Spartanburg, South Carolina, 29303, United States
Prairie Lakes Health Care
Watertown, South Dakota, 57201, United States
Center for Biomedical Research
Knoxville, Tennessee, 37909, United States
Texas Health Physicians Group
Arlington, Texas, 76012, United States
Plano Cancer Institute
Plano, Texas, 75093, United States
The University of Texas Health Science Center at Tyler, Office of Clinical Studies
Tyler, Texas, 75701, United States
Vista Oncology (Shelton office)
Shelton, Washington, 98584, United States
United Hospital Center
Bridgeport, West Virginia, 26330, United States
Camden Clark Medical Center / Regional Cancer Center
Parkersburg, West Virginia, 26101, United States
University of Wisoncsin - Carbone Cancer Ctr
Madison, Wisconsin, 53792, United States
Mid North Coast Cancer Institute Coff Habour Health Campus
Coffs Harbour, New South Wales, NSW 2450, Australia
Mater Misericordiae Limited and Mater Medical Research Institute Limited
South Brisbane, Queensland, QLD 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Ballarat Health Services
Ballarat, Victoria, 3350, Australia
Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad
Blagoevgrad, 2700, Bulgaria
Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas
Burgas, 8000, Bulgaria
Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich
Dobrich, 9300, Bulgaria
Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo
Gabrovo, 5300, Bulgaria
Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte
Panagyurishte, 4500, Bulgaria
Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven
Pleven, 5800, Bulgaria
Clinic of Oncology, UMHAT Pulmed
Plovdiv, 4001, Bulgaria
First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004, Bulgaria
First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia
Sofia, 1303, Bulgaria
Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia
Sofia, 1330, Bulgaria
Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia
Sofia, 1431, Bulgaria
Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia
Sofia, 1756, Bulgaria
Clinic of Oncology, UMHAT SofiaMed
Sofia, 1797, Bulgaria
Clinic of Oncology, MHAT Sveta Marina
Varna, 9010, Bulgaria
Cross Cancer Institute - Clinical Trials Unit
Edmonton, Alberta, T6G 1Z2, Canada
Horizon Health Network - The Moncton Hosoital
Moncton, New Brunswick, E1C 6Z8, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Windsor Regional Hospital Cancer Program
Windsor, Ontario, N8W 2X3, Canada
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
L'Institut Universitaire de Cardiologie et de pneumologie de Quebec
Québec, Quebec, G1V 4G5, Canada
Hopital Nord
Marseille, Alpes-Côte d'Azur, 13915, France
URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
Bron, Auvergne-Rhône-Alpes, 69677, France
URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
Lyon, Auvergne-Rhône-Alpes, 69004, France
Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69945, France
Institut Regional du Cancer de Montpellier
Montpellier, Occitanie, 34298, France
Institut de Cancérologie de l'Ouest - Centre Paul Papin
Angers, Pays de la Loire Region, 49055, France
Clinique Victor Hugo
Le Mans, Pays de la Loire Region, 72000, France
CHU Brest
Brest, 29609, France
Centre François Baclesse
Caen, 14000, France
CHI Créteil
Créteil, 94010, France
Institut Paoli-Calmettes, Service Dòncologie Médicale
Marseille, 13009, France
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint-Herblain, 44805, France
Centre Paul Strauss
Strasbourg, 67065, France
Nouvel Hôpital Civil de Strasbourg
Strasbourg, 67091, France
LTD High Technology Hospital Medcenter
Batumi, 6000, Georgia
LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''
Tbilisi, 0112, Georgia
High Technology Medical Center, University Clinic
Tbilisi, 0144, Georgia
Institute of Clinical Oncology
Tbilisi, 0159, Georgia
Multiprofile Clinic Consillium Medulla
Tbilisi, 0186, Georgia
Princess Margaret Hospital
Kowloon, Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
Queen Mary Hospital
Pokfulam, Hong Kong
Hetenyi Geza Hospital
Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary
Koranyi National Institute of Pulmonology - Horváth
Budapest, 1121, Hungary
Koranyi National Institute of TBC and Pulmonology
Budapest, 1121, Hungary
Korányi National Institute
Budapest, 1121, Hungary
Semmelweis Egyetem AOK Pulmonologiai Klinika
Budapest, 1125, Hungary
Veszprém Megyei Tüdőgyógyintézet
Farkasgyepű, 8582, Hungary
Matrai Gyogyintezet
Mátraháza, 3233, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály
Miskolc, 3529, Hungary
Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza
Tatabánya, 2800, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, 8900, Hungary
Sri Venkateshwara Hospitals
Bangalore, Karnataka, 560076, India
KLES Dr Prabhakar Kore Hospital & MRC
Nehru Nagar, Karnataka, 590010, India
Jaslok Hospital & Research Center
Mumbai, Maharashtra, 400026, India
Deenanath Mangeshkar Hospital
Pune, Maharashtra, 411001, India
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Birla Cancer Centre, SMS Hospital
Jaipur, Rajasthan, 302004, India
Healthcare Global (HCG) Towers
Bangalore, 560020, India
Bhagawan Mahaveer Cancer Hospital
Jaipur, 302017, India
Dipartimento di Oncologia, ARNAS Garibaldi
Catania, 95122, Italy
Istituto Nazionale dei Tumori
Milan, 20123, Italy
Istituto Europeo di Oncologia (IEO), Milano
Milan, Italy
Ospedale Santa Maria della Misericordia, Perugia
Perugia, Italy
Radiation Oncology, Campus Bio-Medico University
Rome, I-00128, Italy
Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena
Siena, I-53100, Italy
A.O.U. San Luigi Gonzaga, Orbassano (Torino)
Torino, Italy
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos
Kaunas, 50161, Lithuania
National Cancer Institute
Vilnius, 08660, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661, Lithuania
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Department of Medicine, Faculty of Medicine
Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, 93586, Malaysia
National Cancer Institute
Putrajaya, 62250, Malaysia
Cebu Doctors University Hospital
Cebu City, 6000, Philippines
Davao Doctors Hospital
Davao City, 8000, Philippines
Manila Doctors Hospital
Manila, 1000, Philippines
St. Luke's Medical Center - Quezon City
Quezon City, 1102, Philippines
St. Luke's Medical Centre
Quezon City, 1102, Philippines
Szpital Specjalistyczny w Prabutach Sp. z o.o
Prabuty, Pomeranian Voivodeship, 82-550, Poland
Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina
Mrozy, 05-320, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, 05-400, Poland
Szpital Chorób Płuc im Św. Józefa w Pilchowicach
Pilchowice, 44-145, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
Poznan, 60-569, Poland
Centrum Onkologii-Instytut im. Sklodowskiej-Curie
Warsaw, 02-781, Poland
Wojskowy Instytut Medyczny
Warsaw, 04-141, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz, Łódź Voivodeship, 90-242, Poland
Oncopremium Team LTD
Baia Mare, 430291, Romania
Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
Medisprof LTD
Cluj-Napoca, 400058, Romania
SC Oncolab LTD
Craiova, 200385, Romania
SC Oncology Center Sf. Nectarie LTD
Craiova, Romania
Emergency County Hospital Satu-Mare, Medical Oncology Clinic
Satu Mare, 440055, Romania
Emergency Hospital ,Sf. Ioan cel Nou'
Suceava, 720224, Romania
Oncocenter Oncology Clinic LTD
Timișoara, 300166, Romania
State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, 163045, Russia
Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region
Kursk, 305524, Russia
Federal State Budgetary Institution, Natiоnal Medical Research Center of Oncology n.a. N.N. Blokhin of Ministry of Healthcare of the Russian Federation
Moscow, 115478, Russia
State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department
Moscow, 143423, Russia
State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"
Moscow, Russia
State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1
Novosibirsk, 630047, Russia
State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary
Novosibirsk, 630108, Russia
Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary
Omsk, 644013, Russia
State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary
Orenburg, 460021, Russia
State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
Center of Palliative Care-Devita LLC
Saint Petersburg, 197183, Russia
BioEq, LLC
Saint Petersburg, 197342, Russia
Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov
Saint Petersburg, 197758, Russia
State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological)
Saint Petersburg, 197758, Russia
Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary
Samara, 443031, Russia
State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital
Yaroslavl, 150054, Russia
State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary
Yekaterinburg, 620036, Russia
St. Jacob´s Hospital Bardejov - Department of Clinical Oncology
Bardejov, 08501, Slovakia
Faculty Hospital Zilina
Žilina, 012 07, Slovakia
Kosin University Gospel Hospital
Busan, 49267, South Korea
Chungbuk National University Hospital
Chungcheongbuk-do, 28644, South Korea
Kyungpook National University Medical Center
Daegu, 41404, South Korea
Kyungpook University Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Medical Centre
Daegu, 42601, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
CHA Bundang Medical Center
Gyeonggi-do, 13496, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Chonnam National University Hwasun Hospital
Jeonnam, 58128, South Korea
Gachon Universtiy Gil Medical Center
Namdong, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Boramae Medical Center
Seoul, 07061, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Wonju Severance Christian Hospital
Wonju-Si, Gangwon-do, 26426, South Korea
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
CHU A Coruña
A Coruña, Galicia, 15006, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital General de Alicante
Alicante, 03010, Spain
Hospital Quirón Dexeus
Barcelona, 08028, Spain
Hospital Universitari Vall d´Hebron
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Instituto Catalán de Oncología (ICO) - Josep Trueta
Girona, 17007, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital General Universitário Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Madrid Norte Sanchinarro
Madrid, 28050, Spain
H. M. Puerta del Sur (H. Móstoles)
Madrid, 28938, Spain
Hospital Regional de Málaga (H. Carlos Haya)
Málaga, 29006, Spain
Complexo Hospitalario Universitario de Ourense (CHUO)
Ourense, 32005, Spain
Hospital Virgen de los Lirios Alcoy
Planta, 03804, Spain
Corporació Sanitària Parc Taulí
Sabadell, 08208, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
Hospital Universitario y Politécnico de La Fe
Valencia, 46026, Spain
Hospital Álvaro Cunqueiro
Vigo, 36312, Spain
Hospital Lozano Blesa
Zaragoza, 50009, Spain
E-Da Hospital
Kaohsiung City, 42445, Taiwan
E-Da Hospital
Kaohsiung City, 82445, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
Chi Mei Hospital, Liouying
Tainan, 736, Taiwan
Chang-Gung Memorial Hospital, Linkou
Taoyuan, 33305, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
National Cancer Institute of Thailand
Bangkok, 10400, Thailand
Siriraj Hopsital
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Naresuan University Hospital
Phitsanulok, 65000, Thailand
Songklanagarind Hospital
Songkhla, 90110, 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 Oblast, 49102, Ukraine
Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre
Uzhhorod, Zakarpattia Oblast, 88000, 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, 58013, 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, 03115, 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)
Odesa, 65055, Ukraine
Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy
Vinnitsya, 21029, Ukraine
Princess Alexandra Hospital
Harlow, Essex, CM20 1QX, United Kingdom
Royal Marsden Hospital
Chelsea, London, SW3 6JJ, United Kingdom
St James' Institute of Oncology
Leeds, LS9 7TF, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
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, Fernandez Nunez 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.
PMID: 35278766DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Program Manager, Oncology
- Organization
- United Therapeutics Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2017
First Posted
March 31, 2017
Study Start
June 1, 2017
Primary Completion
January 27, 2020
Study Completion
March 26, 2020
Last Updated
December 9, 2020
Results First Posted
December 9, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share