Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

December 18, 2015

Primary Completion Date

May 25, 2020

Study Completion Date

February 1, 2022

Conditions
Limited Stage Small Cell Lung CancerSmall Cell Lung Cancer
Interventions
DRUG

Ipilimumab

Induction phase: i.v. 3 mg/kg, once every 3 weeks × 4 cycles, to start within 6-8 weeks (42-56 days) from start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation)

DRUG

Nivolumab

Induction phase: Nivolumab i.v. 1 mg/kg, once every 3 weeks × 4 cycles, to start within 6-8 weeks (42-56 days) from start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation) Maintenance Phase: Nivolumab 240 mg i.v once every 2 weeks for a maximum of 12 months from start of maintenance (the first dose of maintenance nivolumab will be administered 3 weeks after the last IMP doses of induction Phase).

Trial Locations (61)

3000

University Hospital Gasthuisberg, KU Leuven, Leuven

22927

LungenClinic Grosshansdorf GmbH, Großhansdorf

72037

Centre Hospitalier Général, Le Mans

Unknown

Bendigo Hospital, Bendigo

Coffs Harbour Health Campus, Coffs Harbour

Royal Brisbane and Women's Hospital (QLD), Herston

Royal Hobart Hospital, Hobart

NNSWLHD - The Tweed Hospital, Lismore

Austin Hospital, Melbourne

Riverina Cancer Centre, Mount Kuring-Gai

Port Macquarie Base Hospital, Port Macquarie

Epworth HealthCare - Richmond, Richmond

Princess Alexandra Hospital, Woolloongabba

Avignon - Institut Sainte-Catherine, Avignon

Caen - Centre François Baclesse, Caen

CHU, Caen

Percy/Armées, Clamart

Clermont-Ferrand, Clermont-Ferrand

Créteil - CHI, Créteil

CHU, Grenoble

Hôpital Louis Pradel, Lyon

Lyon - Sud, Lyon

AP-HM, Marseille

Centre Hospitalier Universitaire de Montpellier, Montpellier

CH, Mulhouse

CRLCC, Nantes

Nice - CRLCC, Nice

Orléans - CH, Orléans

Paris - Bichat, Paris

Paris - Saint-Louis, Paris

Paris - Tenon, Paris

CHU, Rennes

Nouvel Hôpital Civil, Strasbourg

Suresnes, Suresnes

CHI, Toulon

CHU, Toulouse

CHU, Tours

Institut Gustave Roussy, Villejuif

Klinikum Esslingen, Esslingen am Neckar

Klinikum München-Bogenhausen, München

Thoracic Oncology Centre Munich, München

Pius-Hospital Oldenburg, Oldenburg

Krankenhaus der Barmherzigen Brüder, Trier

Universitätsklinikum Tübingen, Tübingen

VUMC, Amsterdam

Maastro Clinic, Maastricht

Hospital General Universitario Alicante, Alicante

Hospital Universitario Cruces, Barakaldo

Hospital De La Santa Creu I Sant Pau, Barcelona

Clinico San Carlos, Madrid

Hospital Puerta de Hierro, Madrid

Hospital Universitario 12 Octubre, Madrid

Hospital Universitario Fundacion Jimenez Díaz, Madrid

Hospital Universitario Central De Asturias, Oviedo

Hospital Virgen De La Salud, Toledo

Hospital Clínico Universitario De Valencia, Valencia

Centre Hospitalier Universitaire Vaudois, Lausanne

University Hospital Zürich, Zurich

St James' University Hospital, Leeds

Royal Marsden, London

The Christie NHS Foundation Trust, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Intergroupe Francophone de Cancerologie Thoracique

OTHER

collaborator

Ludwig Center for Cancer Research of Lausanne

OTHER

collaborator

Frontier Science Foundation, Hellas

OTHER

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

ETOP IBCSG Partners Foundation

NETWORK