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Brief Title: Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC
Official Title: A Single-arm Phase II Trial of the Addition of Niraparib to Anti-PD-L1 Antibody Maintenance in Patients With SLFN11-positive, Extensive-disease Small Cell Lung Cancer.
Study ID: NCT05718323
Brief Summary: RAISE is an international, multicentre, single-arm phase II trial. The trial treatment consists of the addition of niraparib, 200 mg orally once daily to anti-PD-L1 antibody maintenance. The primary objective of this trial is to assess the clinical efficacy of the addition of niraparib to anti-PD-L1 monoclonal antibody maintenance treatment in patients with SLFN11-positive ED-SCLC which has not progressed following standard first-line chemo-immunotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU - Angers, Angers, , France
Centre Hospitalier d'Avignon, Avignon, , France
Caen - CHU, Caen, , France
Lyon - Centre Léon Bérard, Lyon, , France
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, , Italy
Instituto Europeo di Oncologia (IEO), Milan, , Italy
Santa Maria della Misericordia Hospital, Perugia, , Italy
AULSS2 Marca Trevigiana Treviso, Treviso, , Italy
Complejo Hospitalario Universitario a Coruña, A Coruña, , Spain
ICO Badalona - Hospital Germans Trias i Pujol, Badalona, , Spain
Complejo Hospitalario de Jaén, Jaén, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Madrid, , Spain
Kantonsspital Aarau, Aarau, , Switzerland
Kantonsspital Baden, Baden, , Switzerland
University Hospital Basel, Basel, , Switzerland
Inselspital Bern, Bern, , Switzerland
Kantonsspital St. Gallen, Saint Gallen, , Switzerland
Centre Hospitalier du Valais Romand, Sion, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Name: Markus Joerger, MD-PhD
Affiliation: Department of Medical Oncology, Cantonal Hospital St.Gallen
Role: STUDY_CHAIR