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

NCT ID: NCT03098030

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 483 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-03-26

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).

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dinutuximab

Intervention Type: BIOLOGICAL

Dinutuximab injection, for intravenous (IV) use

Irinotecan

Intervention Type: DRUG

Irinotecan injection, IV infusion

Part 2: Irinotecan

Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle.

Group Type: ACTIVE_COMPARATOR

Irinotecan

Intervention Type: DRUG

Irinotecan injection, IV infusion

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.

Group Type: EXPERIMENTAL

Dinutuximab

Intervention Type: BIOLOGICAL

Dinutuximab injection, for intravenous (IV) use

Irinotecan

Intervention Type: DRUG

Irinotecan injection, IV infusion

Part 2: Topotecan

Topotecan (1.5 mg/m\^2 IV) on Days 1 to 5 of each q21d cycle.

Group Type: ACTIVE_COMPARATOR

Topotecan

Intervention Type: DRUG

Topotecan for injection

Interventions

Dinutuximab

Dinutuximab injection, for intravenous (IV) use

Intervention Type: BIOLOGICAL

Irinotecan

Irinotecan injection, IV infusion

Intervention Type: DRUG

Topotecan

Topotecan for injection

Intervention Type: DRUG

Other Intervention Names

Unituxin®; ch14.18; Camptosar®; Hycamtin®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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

St. 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

Montreal, Quebec, Canada

L'Institut Universitaire de Cardiologie et de pneumologie de Quebec

Québec, Quebec, Canada

Hopital Nord

Marseille, Alpes-Côte d'Azur, France

URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse

Bron, Auvergne-Rhône-Alpes, France

URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse

Lyon, Auvergne-Rhône-Alpes, France

Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Institut Regional du Cancer de Montpellier

Montpellier, Occitanie, France

Institut de Cancérologie de l'Ouest - Centre Paul Papin

Angers, Pays de la Loire Region, France

Clinique Victor Hugo

Le Mans, Pays de la Loire Region, 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, Jász-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

Mátraháza, , Hungary

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály

Miskolc, , Hungary

Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

Tatabánya, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , 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

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, Warmian-Masurian Voivodeship, 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

Poznan, , Poland

Centrum Onkologii-Instytut im. Sklodowskiej-Curie

Warsaw, , Poland

Wojskowy Instytut Medyczny

Warsaw, , Poland

Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

Lodz, 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

Timișoara, , Romania

State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary

Arkhangelsk, , Russia

Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region

Kursk, , 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, , Russia

State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department

Moscow, , 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, , Russia

State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary

Novosibirsk, , Russia

Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary

Omsk, , Russia

State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary

Orenburg, , Russia

State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital

Saint Petersburg, , Russia

Center of Palliative Care-Devita LLC

Saint Petersburg, , Russia

BioEq, LLC

Saint Petersburg, , Russia

Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov

Saint Petersburg, , Russia

State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological)

Saint Petersburg, , Russia

Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary

Saint Petersburg, , Russia

State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary

Samara, , Russia

State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital

Yaroslavl, , Russia

State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary

Yekaterinburg, , Russia

St. Jacob´s Hospital Bardejov - Department of Clinical Oncology

Bardejov, , Slovakia

Faculty Hospital Zilina

Žilina, , Slovakia

Kosin University Gospel Hospital

Busan, , South Korea

Chungbuk National University Hospital

Chungcheongbuk-do, , South Korea

Kyungpook National University Medical Center

Daegu, , South Korea

Kyungpook University Chilgok Hospital

Daegu, , South Korea

Keimyung University Dongsan Medical Centre

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

CHA Bundang Medical Center

Gyeonggi-do, , South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Pusan National University Yangsan Hospital

Gyeongsangnam-do, , South Korea

Inha University Hospital

Incheon, , South Korea

Chonnam National University Hwasun Hospital

Jeonnam, , South Korea

Gachon Universtiy Gil Medical Center

Namdong, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Boramae Medical Center

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Wonju Severance Christian Hospital

Wonju-Si, Gangwon-do, , South Korea

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

CHU A Coruña

A Coruña, Galicia, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, 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

Seville, , 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, , Taiwan

Chi Mei Hospital, Liouying

Tainan City, , Taiwan

Chang-Gung Memorial Hospital, Linkou

Taoyuan, , 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 Oblast, Ukraine

Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre

Uzhhorod, Zakarpattia Oblast, 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)

Odesa, , 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

Countries

United States; Australia; Bulgaria; Canada; France; Georgia; Hong Kong; Hungary; India; Italy; Lithuania; Malaysia; Philippines; Poland; Romania; Russia; Slovakia; South Korea; Spain; Taiwan; Thailand; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35278766 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

DIV-SCLC-301

Identifier Type: -

Identifier Source: org_study_id