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.
RAISE: Niraparib added to anti-PD-L1 antibody maintenance in SLFN11-positive, extensive-disease SCLC

An international, multicentre, single-arm phase II trial in patients with extensive-disease small cell lung cancer and high SLFN11-expression who have not progressed during first-line standard chemo-immunotherapy and are planned for maintenance therapy with immune-checkpoint inhibition .

Trial Scheme

Trial Information

Primary Endpoint:
Progression-free survival (PFS) rate at 3 months by investigator assessment (according to RECIST v1.1)
Secondary Endpoints:
Progression-free survival (PFS)
Overall survival (OS)
Disease control rate (DCR) by investigator assessment (according to RECIST v1.1
Adverse events according to CTCAE v5.0
Target Sample Size:
44 enrolled patients
Protocol Release Date:
21 February 2023
Trial Activation Date:
23 November 2023

Trial Organisation

Trial Chair:
Markus Joerger, St. Gallen, Switzerland
Trial Co-Chair:
Antonio Passaro, Milano, Italy
ETOP IBCSG Partners Foundation
Coordinating Group:
ETOP IBCSG Partners Foundation
Participating Groups:
Swiss Group for Clinical Cancer Research (SAKK) and Spanish Lung Cancer Group (SLCG)
Participating Countries:
France, Italy, Romania, Switzerland, Spain
EU CT number: 2022-502092-33
clinicaltrials.gov: NCT05718323


ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland

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