Last updated on November 2018

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

Brief description of study

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).

Clinical Study Identifier: NCT03098030

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Jorge Nieva, MD

USC Norris Comprehensive Cancer Center
Los Angeles, CA United States

Wylie Hosmer, MD

Hartford Hospital
Hartford, CT United States

Dennis Slater, MD

Eastern Connecticut Hematology and Oncology Assoc
Norwich, CT United States

Troy Guthrie, MD

21st Century Oncology
Jacksonville, FL United States

Naveed Chowhan, MD

Baptist Health Floyd Cancer Center
New Albany, IN United States

Samuel Bailey, MD

Kentucky Cancer Clinic
Hazard, KY United States

raymond Lobins, MD

Cox Health Medical
Springfield, MO United States

Patrick Cobb, MD

St. Vincent Frontier Cancer Center
Billings, MT United States

Afshin Dowlati, MD

UH Cleveland Medical Center
Cleveland, OH United States

Theodore Pollock, MD

Cancer Treatment Centers of America at Southwestern RMC
Tulsa, OK United States

David Ellison, MD

Charleston Hematology Oncology Assoc.
Charleston, SC United States

Ruben Saez, MD

Plano Cancer Institute
Plano, TX United States

Arielle Lee, MD

Hope Cancer Center of East Texas
Tyler, TX United States

Joseph Ye, MD

Vista Oncology (Shelton office)
Shelton, WA United States

Ticiana Leal, MD

University of Wisoncsin - UW Carbone Cancer Ctr
Madison, WI United States

Alejandro Navarro Mendivil, MD

Hospital Universitari Vall d Hebron
Barcelona, Spain

Rosa Alvarez Alvarez, MD

Hospital General Universit rio Gregorio Mara n
Madrid, Spain

Javier de Castro Carpeño, MD

Hospital Universitario La Paz
Madrid, Spain

Javier de Castro Carpeño, MD

Hospital Universitario Madrid Norte Sanchinarro
Madrid, Spain

Martin Emilio Lázaro Quintela, MD

"Fundaci n Biom dica Galicia Sur
Pontevedra, Spain

Osca Juan Vidal, MD

Hospital Universitario y Polit cnico de La Fe
Valencia, Spain

Roy Timothy Webb, MD

Genesis Cancer Center
Hot Springs, AR United States

Arati Chand, MD

Innovative Clinical Research Institute
Whittier, CA United States

Steven McCune, MD

Northwest Georgia Oncology Centers, P.C.
Marietta, GA United States

William Fusselman, MD

Physicians' Clinic of Iowa Hematology and Oncology
Cedar Rapids, IA United States

Jesus Fabregas, MD

Billings Clinic Cancer Center
Billings, MT United States

Shayma Kazmi, MD

Cancer Treatment Centers of America at Eastern Regional Medical Center
Philadelphia, PA United States

Alfred DiStefano, MD

Texas Health Physicians Group
Arlington, TX United States

Salman Osman, MD

United Hospital Center
Bridgeport, WV United States

Nimit Singhal, MD

Royal Adelaide Hospital
Adelaide, Australia

Wasek Faisal, MD

Ballarat Health Services
Ballarat, Australia

Ankit Jain, MD

Mid North Coast Cancer Institute Coff Habour Health Campus
Coffs Harbour, Australia

Vikram Jain, MD

Mater Misericordiae Limited and Mater Medical Research Institute Limited
South Brisbane, Australia

Antoaneta Katsarska, MD

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

Hristo Dechev, MD

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

Zyuhal Kasimova, MD

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

Rossitsa Krasteva, MD

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

Tatyana Koynova, MD

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

Spartak Valev, MD

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

Maya Tsakova, MD

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

Galina Kurteva, MD

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

Mahmoud Abdelsalam, MD

Horizon Health Network - The Moncton Hosoital
Moncton, NB Canada

Gilles Robinet, MD

CHU Brest
Brest, France

Radj Gervais, MD

Centre Fran ois Baclesse
Caen, France

Anne Madroszyk, MD

Institut Paoli-Calmettes, Service d ncologie m dicale
Marseille, France

Roland Schott, MD

Centre Paul Strauss
Strasbourg, France

Miranda Gogishvili, MD

High Technology Medical Center, University Clinic
Tbilisi, Georgia

Tsira Kortua, MD

Multiprofile Clinic Consillium Medulla
Tbilisi, Georgia

Ashley Chi Kin Cheng, MD

Princess Margaret Hospital
Kowloon, Hong Kong

James Chung-man Ho, MD

Queen Mary Hospital
Pokfulam, Hong Kong

Horváth Ildiko, Prof

Koranyi National Institute of Pulmonology - Horv th
Budapest, Hungary

Katakin Udud, MD

Koranyi National Institute of TBC and Pulmonology
Budapest, Hungary

Urban Laszlo, MD

Matrai Gyogyintezet
Matrahaza, Hungary

Ashish Sangal, MD

Cancer Treatment Centers of America - Western Regional Medical Center
Goodyear, AZ United States

Jai Joshi, MD

Innovative Clinical Research Institute
Tucson, AZ United States

Natasha Banarjee, MD

Olive View - UCLA
Sylmar, CA United States

Pratibha Desai, MD

Pinellas Hematology and Oncology
Saint Petersburg, FL United States

Taofeek Owonikoko, MD

Winship Cancer Institute, Emory University
Atlanta, GA United States

Susanne Arnold, MD

University of Kentucky
Lexington, KY United States

Vijay Raghavan, MD

21st Century Oncology
Louisville, KY United States

Bipinkumar Amin, MD

Prairie Lakes Health Care
Watertown, SD United States

Millie Das, MD

VA Palo Alto Health Care System
Palo Alto, CA United States

Vincent Chiu, MD

The University of New Mexico Comprehensive Cancer Center
Albuquerque, NM United States

Abderrahim Khomani, MD

Spartanburg Medical Center/Gibbs Cancer Center and Research Institute
Spartanburg, SC United States

Nik Shah, MD

Camden Clark Medical Center / Regional Cancer Center
Parkersburg, WV United States

Anil Joy, MD

Cross Cancer Institute - Clinical Trials Unit
Edmonton, AB Canada

Natasha Leighl, MD

Princess Margaret Cancer Centre
Toronto, ON Canada

Tarek Elfiki, MD

Windsor Regional Hospital Cancer Program
Windsor, ON Canada

Anne Madroszyk, MD

Institut Paoli-Calmettes, Service D ncologie M dicale
Marseille, France

Musaberk Goksel, MD

Alaska Clinical Research Center
Anchorage, AK United States

Bonka Popova, MD

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

Antoaneta Tomova, MD

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

Tamta Makharadze, MD

Cancer Center of Adjara Autonomus Republic
Batumi, Georgia

Vladimier Kuchava, MD

Institute of Clinical Oncology
Tbilisi, Georgia

Leung Hoi Leung, MD

Queen Elizabeth Hospital
Kowloon, Hong Kong

Laurent Greillier, MD

Hopital Nord
Marseille, France

Ivane Kiladze, M.D.

LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''
Tbilisi, Georgia

Santosh Nair, MD

Mid Florida Hematology Oncology
Lake Mary, FL United States

Sandeep Mashru, MD

Kaiser Permanente Northwest Center for Health Research CRSS
Portland, OR United States

Martin Edelman, MD

Fox Chase Cancer Center Office of Clinical Research
Philadelphia, PA United States

Russell Devore, MD

Center for Biomedical Research
Knoxville, TN United States

Sandrine Hiret, MD

Institut de Canc rologie de l'Ouest - Centre Paul Papin
Angers, France

Gillies Domont, MD

Clinique Victor Hugo
Le Mans, France

Pierre Jean Souquet, MD

URCOT : Unit de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'h pital de la Croix-Rousse
Bron, France

Pierre Jean Souquet, MD

URCOT : Unit de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'h pital de la Croix-Rousse
Lyon, France

Sandrine Hiret, MD

Institut de Canc rologie de l'Ouest - Centre Ren Gauducheau
Saint-Herblain, France

Xavier Quantin, MD

Institut Regional du Cancer de Montpellier
Montpellier, France

Natalya Petrova, MD

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

Tatyana Apostolova, MD

Clinic of Oncology, UMHAT Pulmed
Plovdiv, Bulgaria

Velko Minchev, MD

Clinic of Oncology, UMHAT SofiaMed
Sofia, Bulgaria

Asen Yanchev, MD

Clinic of Oncology, MHAT Sveta Marina
Varna, Bulgaria

Vera Hirsh, MD

McGill University Health Center
Montréal, QC Canada

Catherine Labbé, MD

L'Institut Universitaire de Cardiologie et de pneumologie de Quebec
Québec, QC Canada

Pierre Jean Souquet, MD

Service de Pneumologie aigu et Canc rologie Thoracique Centre hospitalier Lyon-Sud
Pierre Bénite, France

Chouaid Chrsitos, Prof

CHI Cr teil
Créteil, France

Elisabeth Quoix, MD

Nouvel H pital Civil de Strasbourg
Strasbourg, France

Recruitment Status: Closed

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