AzTrials
AzTrials

Small Cell Lung CancerPhase 2/3NCT03098030

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

A Phase 2/3 study testing Dinutuximab, Irinotecan and Topotecan in people with Small Cell Lung Cancer, run by United Therapeutics at 226 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Dinutuximab, Irinotecan and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
483 participants
Where
226 sitesin 23 countries
Study dates
1 Jun 2017to 26 Mar 2020
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

226 sites in 23 countries.

226 sites in 23 countries

United States40 sites

  • The University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

  • Alaska Clinical Research Center

    Anchorage, Alaska, 99503

  • Texas Health Physicians Group

    Arlington, Texas, 76012

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • United Hospital Center

    Bridgeport, West Virginia, 26330

  • Physicians' Clinic of Iowa Hematology and Oncology

    Cedar Rapids, Iowa, 52403

  • Charleston Oncology

    Charleston, South Carolina, 29414

  • UH Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Alpha Oncology Research LLC

    DeBary, Florida, 32713

  • Cancer Treatment Centers of America - Western Regional Medical Center

    Goodyear, Arizona, 85338

  • Hartford Hospital

    Hartford, Connecticut, 06062

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • 21st Century Oncology

    Jacksonville, Florida, 32204

  • Center for Biomedical Research

    Knoxville, Tennessee, 37909

  • University of Kentucky

    Lexington, Kentucky, 40506

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • 21st Century Oncology

    Louisville, Kentucky, 40215

  • University of Wisoncsin - Carbone Cancer Ctr

    Madison, Wisconsin, 53792

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • Baptist Health Floyd Cancer Center

    New Albany, Indiana, 47150

  • Eastern Connecticut Hematology and Oncology Assoc

    Norwich, Connecticut, 06360

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Camden Clark Medical Center / Regional Cancer Center

    Parkersburg, West Virginia, 26101

  • Fox Chase Cancer Center Office of Clinical Research

    Philadelphia, Pennsylvania, 19111

  • Cancer Treatment Centers of America at Eastern Regional Medical Center

    Philadelphia, Pennsylvania, 19124

  • Plano Cancer Institute

    Plano, Texas, 75093

  • Kaiser Permanente Northwest Center for Health Research CRSS

    Portland, Oregon, 97227

  • Vista Oncology (Shelton office)

    Shelton, Washington, 98584

  • Spartanburg Medical Center/Gibbs Cancer Center and Research Institute

    Spartanburg, South Carolina, 29303

  • Cox Health Medical

    Springfield, Missouri, 65807

  • Comprehensive Hematology Oncology

    St. Petersburg, Florida, 33709

  • Olive View - UCLA

    Sylmar, California, 91342

  • Innovative Clinical Research Institute

    Tucson, Arizona, 85745

  • Cancer Treatment Centers of America at Southwestern RMC

    Tulsa, Oklahoma, 74133

  • The University of Texas Health Science Center at Tyler, Office of Clinical Studies

    Tyler, Texas, 75701

  • Prairie Lakes Health Care

    Watertown, South Dakota, 57201

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Spain23 sites

  • CHU A Coruña

    A Coruña, Galicia, 15006

  • Hospital General de Alicante

    Alicante, 03010

  • Hospital Quirón Dexeus

    Barcelona, 08028

  • Hospital Universitari Vall d´Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Instituto Catalán de Oncología (ICO) - Josep Trueta

    Girona, 17007

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital General Universitário Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Madrid Norte Sanchinarro

    Madrid, 28050

  • H. M. Puerta del Sur (H. Móstoles)

    Madrid, 28938

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Regional de Málaga (H. Carlos Haya)

    Málaga, 29006

  • Complexo Hospitalario Universitario de Ourense (CHUO)

    Ourense, 32005

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Virgen de los Lirios Alcoy

    Planta, 03804

  • Corporació Sanitària Parc Taulí

    Sabadell, 08208

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen de Valme

    Seville, 41014

  • Hospital Universitario y Politécnico de La Fe

    Valencia, 46026

  • Hospital Álvaro Cunqueiro

    Vigo, 36312

  • Hospital Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Russia18 sites

  • State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary

    Arkhangelsk, 163045

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

    Kursk, 305524

  • 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

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

    Moscow, 143423

  • State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"

    Moscow

  • State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1

    Novosibirsk, 630047

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

    Novosibirsk, 630108

  • Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary

    Omsk, 644013

  • State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary

    Orenburg, 460021

  • State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • Center of Palliative Care-Devita LLC

    Saint Petersburg, 197183

  • BioEq, LLC

    Saint Petersburg, 197342

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

    Saint Petersburg, 197758

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

    Saint Petersburg, 197758

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

    Saint Petersburg, 198255

  • State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary

    Samara, 443031

  • State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital

    Yaroslavl, 150054

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

    Yekaterinburg, 620036

Other trials in Russia

South Korea16 sites

  • Kosin University Gospel Hospital

    Busan, 49267

  • Chungbuk National University Hospital

    Chungcheongbuk-do, 28644

  • Kyungpook National University Medical Center

    Daegu, 41404

  • Kyungpook University Chilgok Hospital

    Daegu, 41404

  • Keimyung University Dongsan Medical Centre

    Daegu, 42601

  • Chungnam National University Hospital

    Daejeon, 35015

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Pusan National University Yangsan Hospital

    Gyeongsangnam-do, 50612

  • Inha University Hospital

    Incheon, 22332

  • Chonnam National University Hwasun Hospital

    Jeonnam, 58128

  • Gachon Universtiy Gil Medical Center

    Namdong

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Boramae Medical Center

    Seoul, 07061

  • Ulsan University Hospital

    Ulsan, 44033

  • Wonju Severance Christian Hospital

    Wonju-Si, Gangwon-do, 26426

Other trials in South Korea

Bulgaria14 sites

  • Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad

    Blagoevgrad, 2700

  • Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas

    Burgas, 8000

  • Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich

    Dobrich, 9300

  • Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo

    Gabrovo, 5300

  • Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte

    Panagyurishte, 4500

  • Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven

    Pleven, 5800

  • Clinic of Oncology, UMHAT Pulmed

    Plovdiv, 4001

  • First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004

  • First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia

    Sofia, 1303

  • Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia

    Sofia, 1330

  • Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia

    Sofia, 1431

  • Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia

    Sofia, 1756

  • Clinic of Oncology, UMHAT SofiaMed

    Sofia, 1797

  • Clinic of Oncology, MHAT Sveta Marina

    Varna, 9010

Other trials in Bulgaria

France14 sites

  • Institut de Cancérologie de l'Ouest - Centre Paul Papin

    Angers, Pays de la Loire Region, 49055

  • CHU Brest

    Brest, 29609

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

    Bron, Auvergne-Rhône-Alpes, 69677

  • Centre François Baclesse

    Caen, 14000

  • CHI Créteil

    Créteil, 94010

  • Clinique Victor Hugo

    Le Mans, Pays de la Loire Region, 72000

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

    Lyon, Auvergne-Rhône-Alpes, 69004

  • Hopital Nord

    Marseille, Alpes-Côte d'Azur, 13915

  • Institut Paoli-Calmettes, Service Dòncologie Médicale

    Marseille, 13009

  • Institut Regional du Cancer de Montpellier

    Montpellier, Occitanie, 34298

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

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69945

  • Institut de Cancérologie de l'Ouest - Centre René Gauducheau

    Saint-Herblain, 44805

  • Centre Paul Strauss

    Strasbourg, 67065

  • Nouvel Hôpital Civil de Strasbourg

    Strasbourg, 67091

Other trials in France

Hungary11 sites

  • Koranyi National Institute of Pulmonology - Horváth

    Budapest, 1121

  • Koranyi National Institute of TBC and Pulmonology

    Budapest, 1121

  • Korányi National Institute

    Budapest, 1121

  • Semmelweis Egyetem AOK Pulmonologiai Klinika

    Budapest, 1125

  • Veszprém Megyei Tüdőgyógyintézet

    Farkasgyepű, 8582

  • Matrai Gyogyintezet

    Mátraháza, 3233

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

    Miskolc, 3529

  • Hetenyi Geza Hospital

    Szolnok, Jász-Nagykun-Szolnok, 5004

  • Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

    Tatabánya, 2800

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Poland9 sites

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

    Lodz, Łódź Voivodeship, 90-242

  • Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina

    Mrozy, 05-320

  • Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

  • Szpital Chorób Płuc im Św. Józefa w Pilchowicach

    Pilchowice, 44-145

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

    Poznan, 60-569

  • Szpital Specjalistyczny w Prabutach Sp. z o.o

    Prabuty, Pomeranian Voivodeship, 82-550

  • Centrum Onkologii-Instytut im. Sklodowskiej-Curie

    Warsaw, 02-781

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

Other trials in Poland

India8 sites

  • Sri Venkateshwara Hospitals

    Bangalore, Karnataka, 560076

  • Healthcare Global (HCG) Towers

    Bangalore, 560020

  • Birla Cancer Centre, SMS Hospital

    Jaipur, Rajasthan, 302004

  • Bhagawan Mahaveer Cancer Hospital

    Jaipur, 302017

  • Jaslok Hospital & Research Center

    Mumbai, Maharashtra, 400026

  • KLES Dr Prabhakar Kore Hospital & MRC

    Nehru Nagar, Karnataka, 590010

  • Deenanath Mangeshkar Hospital

    Pune, Maharashtra, 411001

  • Grant Medical Foundation Ruby Hall Clinic

    Pune, Maharashtra, 411001

Other trials in India

Romania8 sites

  • Oncopremium Team LTD

    Baia Mare, 430291

  • Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

  • Medisprof LTD

    Cluj-Napoca, 400058

  • SC Oncolab LTD

    Craiova, 200385

  • SC Oncology Center Sf. Nectarie LTD

    Craiova

  • Emergency County Hospital Satu-Mare, Medical Oncology Clinic

    Satu Mare, 440055

  • Emergency Hospital ,Sf. Ioan cel Nou'

    Suceava, 720224

  • Oncocenter Oncology Clinic LTD

    Timișoara, 300166

Other trials in Romania

Italy7 sites

  • Dipartimento di Oncologia, ARNAS Garibaldi

    Catania, 95122

  • Istituto Nazionale dei Tumori

    Milan, 20123

  • Istituto Europeo di Oncologia (IEO), Milano

    Milan

  • Ospedale Santa Maria della Misericordia, Perugia

    Perugia

  • Radiation Oncology, Campus Bio-Medico University

    Rome, I-00128

  • Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena

    Siena, I-53100

  • A.O.U. San Luigi Gonzaga, Orbassano (Torino)

    Torino

Other trials in Italy

Thailand7 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • National Cancer Institute of Thailand

    Bangkok, 10400

  • Siriraj Hopsital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Naresuan University Hospital

    Phitsanulok, 65000

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

United Kingdom7 sites

  • Royal Marsden Hospital

    Chelsea, London, SW3 6JJ

  • Princess Alexandra Hospital

    Harlow, Essex, CM20 1QX

  • St James' Institute of Oncology

    Leeds, LS9 7TF

  • St Bartholomew's Hospital

    London, EC1A 7BE

  • Royal Free Hospital

    London, NW3 2QG

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Canada6 sites

  • Cross Cancer Institute - Clinical Trials Unit

    Edmonton, Alberta, T6G 1Z2

  • Horizon Health Network - The Moncton Hosoital

    Moncton, New Brunswick, E1C 6Z8

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • L'Institut Universitaire de Cardiologie et de pneumologie de Quebec

    Québec, Quebec, G1V 4G5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Windsor Regional Hospital Cancer Program

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Taiwan6 sites

  • E-Da Hospital

    Kaohsiung City, 42445

  • E-Da Hospital

    Kaohsiung City, 82445

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Chung Shan Medical University Hospital

    Taichung, 402

  • Chi Mei Hospital, Liouying

    Tainan, 736

  • Chang-Gung Memorial Hospital, Linkou

    Taoyuan City, 33305

Other trials in Taiwan

Ukraine6 sites

  • 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

  • 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

  • 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

  • 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

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

    Uzhhorod, Zakarpattia Oblast, 88000

  • Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy

    Vinnitsya, 21029

Other trials in Ukraine

Georgia5 sites

  • LTD High Technology Hospital Medcenter

    Batumi, 6000

  • LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''

    Tbilisi, 0112

  • High Technology Medical Center, University Clinic

    Tbilisi, 0144

  • Institute of Clinical Oncology

    Tbilisi, 0159

  • Multiprofile Clinic Consillium Medulla

    Tbilisi, 0186

Other trials in Georgia

Philippines5 sites

  • Cebu Doctors University Hospital

    Cebu City, 6000

  • Davao Doctors Hospital

    Davao City, 8000

  • Manila Doctors Hospital

    Manila, 1000

  • St. Luke's Medical Center - Quezon City

    Quezon City, 1102

  • St. Luke's Medical Centre

    Quezon City, 1102

Other trials in Philippines

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Ballarat Health Services

    Ballarat, Victoria, 3350

  • Mid North Coast Cancer Institute Coff Habour Health Campus

    Coffs Harbour, New South Wales, NSW 2450

  • Mater Misericordiae Limited and Mater Medical Research Institute Limited

    South Brisbane, Queensland, QLD 4101

Other trials in Australia

Malaysia4 sites

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • Department of Medicine, Faculty of Medicine

    Kuala Lumpur

  • Hospital Umum Sarawak

    Kuching, 93586

  • National Cancer Institute

    Putrajaya, 62250

Other trials in Malaysia

Hong Kong3 sites

  • Princess Margaret Hospital

    Kowloon

  • Queen Elizabeth Hospital

    Kowloon

  • Queen Mary Hospital

    Pokfulam

Other trials in Hong Kong

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos

    Kaunas, 50161

  • National Cancer Institute

    Vilnius, 08660

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, 08661

Other trials in Lithuania

Slovakia2 sites

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

    Bardejov, 08501

  • Faculty Hospital Zilina

    Žilina, 012 07

Other trials in Slovakia

About this study

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

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).

Being tested
Dinutuximab, Irinotecan, Topotecan
Keywords
Dinutuximab, Irinotecan, Topotecan
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DinutuximabBiological

    Also called Unituxin®, ch14.18

    Dinutuximab injection, for intravenous (IV) use

  • IrinotecanDrug

    Also called Camptosar®

    Irinotecan injection, IV infusion

  • TopotecanDrug

    Also called Hycamtin®

    Topotecan for injection

Study groups in NCT03098030
Study groupRoleWhat they receive
Part 1: Dinutuximab + IrinotecanExperimentalDinutuximab (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.
Receives: Biological: Dinutuximab; Drug: Irinotecan
Part 2: IrinotecanActive comparatorIrinotecan (350 mg/m^2 IV) on Day 1 of each q21d cycle.
Receives: Drug: Irinotecan
Part 2: Dinutuximab + IrinotecanExperimentalDinutuximab (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.
Receives: Biological: Dinutuximab; Drug: Irinotecan
Part 2: TopotecanActive comparatorTopotecan (1.5 mg/m^2 IV) on Days 1 to 5 of each q21d cycle.
Receives: Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 2.5 years

Secondary outcomes (3)

  1. 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.

    Measured: Up to approximately 2.5 years

  2. 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.

    Measured: Up to approximately 2.5 years

  3. 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 .

    Measured: Up to approximately 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2017
  2. Study start1 Jun 2017
  3. Primary completion27 Jan 2020
  4. Study completion26 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
483 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03098030
Sponsor's protocol ID
DIV-SCLC-301
Status last verified
Nov 2020
First submitted
22 Mar 2017
Last updated
9 Dec 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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, 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.

    PubMed 35278766

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dinutuximab, Irinotecan and Topotecan in people with Small Cell Lung Cancer, run by United Therapeutics at 226 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Spain, Russia, South Korea, Bulgaria and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03098030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in