Clinical trial NCT03098030: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Small Cell Lung Cancer
Keywords: Dinutuximab
Irinotecan
Topotecan
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-03-31
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 2.5 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 2.5 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 2.5 years
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to approximately 2.5 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Clinical Research Center
state: Alaska
city: Goodyear
country: United States
facility: Cancer Treatment Centers of America - Western Regional Medical Center
state: Arizona
city: Tucson
country: United States
facility: Innovative Clinical Research Institute
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Sylmar
country: United States
facility: Olive View - UCLA
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Assoc
state: Connecticut
city: DeBary
country: United States
facility: Alpha Oncology Research LLC
state: Florida
city: Jacksonville
country: United States
facility: 21st Century Oncology
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive Hematology Oncology
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: New Albany
country: United States
facility: Baptist Health Floyd Cancer Center
state: Indiana
city: Cedar Rapids
country: United States
facility: Physicians' Clinic of Iowa Hematology and Oncology
state: Iowa
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: 21st Century Oncology
state: Kentucky
city: Springfield
country: United States
facility: Cox Health Medical
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Albuquerque
country: United States
facility: The University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America at Southwestern RMC
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Northwest Center for Health Research CRSS
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center Office of Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America at Eastern Regional Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Oncology
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center/Gibbs Cancer Center and Research Institute
state: South Carolina
city: Watertown
country: United States
facility: Prairie Lakes Health Care
state: South Dakota
city: Knoxville
country: United States
facility: Center for Biomedical Research
state: Tennessee
city: Arlington
country: United States
facility: Texas Health Physicians Group
state: Texas
city: Plano
country: United States
facility: Plano Cancer Institute
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler, Office of Clinical Studies
state: Texas
city: Shelton
country: United States
facility: Vista Oncology (Shelton office)
state: Washington
city: Bridgeport
country: United States
facility: United Hospital Center
state: West Virginia
city: Parkersburg
country: United States
facility: Camden Clark Medical Center / Regional Cancer Center
state: West Virginia
city: Madison
country: United States
facility: University of Wisoncsin - Carbone Cancer Ctr
state: Wisconsin
city: Coffs Harbour
country: Australia
facility: Mid North Coast Cancer Institute Coff Habour Health Campus
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited and Mater Medical Research Institute Limited
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Ballarat
country: Australia
facility: Ballarat Health Services
state: Victoria
city: Blagoevgrad
country: Bulgaria
facility: Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad
city: Burgas
country: Bulgaria
facility: Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas
city: Dobrich
country: Bulgaria
facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich
city: Gabrovo
country: Bulgaria
facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo
city: Panagyurishte
country: Bulgaria
facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte
city: Pleven
country: Bulgaria
facility: Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven
city: Plovdiv
country: Bulgaria
facility: Clinic of Oncology, UMHAT Pulmed
city: Plovdiv
country: Bulgaria
facility: First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia
city: Sofia
country: Bulgaria
facility: Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia
city: Sofia
country: Bulgaria
facility: Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia
city: Sofia
country: Bulgaria
facility: Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia
city: Sofia
country: Bulgaria
facility: Clinic of Oncology, UMHAT SofiaMed
city: Varna
country: Bulgaria
facility: Clinic of Oncology, MHAT Sveta Marina
city: Edmonton
country: Canada
facility: Cross Cancer Institute - Clinical Trials Unit
state: Alberta
city: Moncton
country: Canada
facility: Horizon Health Network - The Moncton Hosoital
state: New Brunswick
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Hospital Cancer Program
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Québec
country: Canada
facility: L'Institut Universitaire de Cardiologie et de pneumologie de Quebec
state: Quebec
city: Marseille
country: France
facility: Hopital Nord
state: Alpes-Côte d'Azur
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier
state: Occitanie
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin
state: Pays De La Loire
city: Le Mans
country: France
facility: Clinique Victor Hugo
state: Pays De La Loire
city: Bron
country: France
facility: URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
state: Rhône-Alpes
city: Lyon
country: France
facility: URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse
state: Rhône-Alpes
city: Pierre Bénite
country: France
facility: Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud
state: Rhône-Alpes
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: Centre François Baclesse
city: Créteil
country: France
facility: CHI Créteil
city: Marseille
country: France
facility: Institut Paoli-Calmettes, Service Dòncologie Médicale
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil de Strasbourg
city: Batumi
country: Georgia
facility: LTD High Technology Hospital Medcenter
city: Tbilisi
country: Georgia
facility: LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''
city: Tbilisi
country: Georgia
facility: High Technology Medical Center, University Clinic
city: Tbilisi
country: Georgia
facility: Institute of Clinical Oncology
city: Tbilisi
country: Georgia
facility: Multiprofile Clinic Consillium Medulla
city: Kowloon
country: Hong Kong
facility: Princess Margaret Hospital
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Pokfulam
country: Hong Kong
facility: Queen Mary Hospital
city: Szolnok
country: Hungary
facility: Hetenyi Geza Hospital
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Koranyi National Institute of Pulmonology - Horváth
city: Budapest
country: Hungary
facility: Koranyi National Institute of TBC and Pulmonology
city: Budapest
country: Hungary
facility: Korányi National Institute
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK Pulmonologiai Klinika
city: Farkasgyepű
country: Hungary
facility: Veszprém Megyei Tüdőgyógyintézet
city: Matrahaza
country: Hungary
facility: Matrai Gyogyintezet
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály
city: Tatabanya
country: Hungary
facility: Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz
city: Bangalore
country: India
facility: Sri Venkateshwara Hospitals
state: Karnataka
city: Nehru Nagar
country: India
facility: KLES Dr Prabhakar Kore Hospital & MRC
state: Karnataka
city: Mumbai
country: India
facility: Jaslok Hospital & Research Center
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation Ruby Hall Clinic
state: Maharashtra
city: Jaipur
country: India
facility: Birla Cancer Centre, SMS Hospital
state: Rajasthan
city: Bangalore
country: India
facility: Healthcare Global (HCG) Towers
city: Jaipur
country: India
facility: Bhagawan Mahaveer Cancer Hospital
city: Catania
country: Italy
facility: Dipartimento di Oncologia, ARNAS Garibaldi
city: Milan
country: Italy
facility: Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia (IEO), Milano
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia, Perugia
city: Rome
country: Italy
facility: Radiation Oncology, Campus Bio-Medico University
city: Siena
country: Italy
facility: Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena
city: Torino
country: Italy
facility: A.O.U. San Luigi Gonzaga, Orbassano (Torino)
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Chungcheongbuk-do
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook University Chilgok Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Centre
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Namdong
country: Korea, Republic of
facility: Gachon Universtiy Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju-Si, Gangwon-do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Department of Medicine, Faculty of Medicine
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Putrajaya
country: Malaysia
facility: National Cancer Institute
city: Cebu City
country: Philippines
facility: Cebu Doctors University Hospital
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Manila
country: Philippines
facility: Manila Doctors Hospital
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center - Quezon City
city: Quezon City
country: Philippines
facility: St. Luke's Medical Centre
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny w Prabutach Sp. z o.o
state: Pomeranian Voivodeship
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie
state: Warminsko-Mazurskie
city: Mrozy
country: Poland
facility: Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
city: Pilchowice
country: Poland
facility: Szpital Chorób Płuc im Św. Józefa w Pilchowicach
city: Poznań
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Łódź
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
state: Łódź Voivodeship
city: Baia-Mare
country: Romania
facility: Oncopremium Team LTD
city: Cluj-Napoca
country: Romania
facility: Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca
city: Cluj-Napoca
country: Romania
facility: Medisprof LTD
city: Craiova
country: Romania
facility: SC Oncolab LTD
city: Craiova
country: Romania
facility: SC Oncology Center Sf. Nectarie LTD
city: Satu-Mare
country: Romania
facility: Emergency County Hospital Satu-Mare, Medical Oncology Clinic
city: Suceava
country: Romania
facility: Emergency Hospital ,Sf. Ioan cel Nou'
city: Timisoara
country: Romania
facility: Oncocenter Oncology Clinic LTD
city: Arkhangelsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary
city: Ekaterinburg
country: Russian Federation
facility: State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary
city: Kursk
country: Russian Federation
facility: Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution, Natiоnal Medical Research Center of Oncology n.a. N.N. Blokhin of Ministry of Healthcare of the Russian Federation
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary
city: Orenburg
country: Russian Federation
facility: State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Center of Palliative Care-Devita LLC
city: Saint-Petersburg
country: Russian Federation
facility: State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital
city: Saint-Petersburg
country: Russian Federation
facility: BioEq, LLC
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov
city: Saint-Petersburg
country: Russian Federation
facility: State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological)
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
city: Samara
country: Russian Federation
facility: State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital
city: Bardejov
country: Slovakia
facility: St. Jacob´s Hospital Bardejov - Department of Clinical Oncology
city: Žilina
country: Slovakia
facility: Faculty Hospital Zilina
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Coruña
country: Spain
facility: CHU A Coruña
state: Galicia
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Quirón Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d´Hebron
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Girona
country: Spain
facility: Instituto Catalán de Oncología (ICO) - Josep Trueta
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital General Universitário Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Norte Sanchinarro
city: Madrid
country: Spain
facility: H. M. Puerta del Sur (H. Móstoles)
city: Málaga
country: Spain
facility: Hospital Regional de Málaga (H. Carlos Haya)
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense (CHUO)
city: Planta
country: Spain
facility: Hospital Virgen de los Lirios Alcoy
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico de La Fe
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Lozano Blesa
city: Kaohsiung City
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung City
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital, Liouying
city: Taoyuan City
country: Taiwan
facility: Chang-Gung Memorial Hospital, Linkou
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: National Cancer Institute of Thailand
city: Bangkok
country: Thailand
facility: Siriraj Hopsital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Phitsanulok
country: Thailand
facility: Naresuan University Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Dnipro
country: Ukraine
facility: 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
state: Dnipropetrovsk
city: Uzhgorod
country: Ukraine
facility: Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre
state: Zakarpattia
city: Chernivtsi
country: Ukraine
facility: 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
city: Kiev
country: Ukraine
facility: 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
city: Odessa
country: Ukraine
facility: 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)
city: Vinnitsya
country: Ukraine
facility: Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
state: Essex
city: Chelsea
country: United Kingdom
facility: Royal Marsden Hospital
state: London
city: Leeds
country: United Kingdom
facility: St James' Institute of Oncology
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
References:
citation: 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.