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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
200 mg orally once daily, until PD 300 mg once daily if body weight ≥77 kg and platelets ≥150 g/L, until PD
CHU - Angers
Angers, France
RECRUITINGCentre Hospitalier d'Avignon
Avignon, France
RECRUITINGCaen - CHU
Caen, France
RECRUITINGLyon - Centre Léon Bérard
Lyon, France
NOT_YET_RECRUITINGIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, Italy
RECRUITINGInstituto Europeo di Oncologia (IEO)
Milan, Italy
NOT_YET_RECRUITINGSanta Maria della Misericordia Hospital
Perugia, Italy
RECRUITINGAULSS2 Marca Trevigiana Treviso
Treviso, Italy
NOT_YET_RECRUITINGComplejo Hospitalario Universitario a Coruña
A Coruña, Spain
NOT_YET_RECRUITINGComplejo Hospitalario de Jaén
Jaén, Spain
RECRUITING...and 8 more locations
Progression-free survival (PFS) rate at 3 months by investigator assessment (according to RECIST v1.1)
Defined as the rate of patients without a PFS event at 3 months after enrolment
Time frame: From date of enrolment until 3 months post-enrolment
Progression-free survival (PFS)
Defined as the time from the date of enrolment until documented progression
Time frame: From the date of enrolment until last tumour assessment (approximately 25-30 months after the enrolment of the first patient)
Overall survival (OS)
Defined as the time from the date of enrolment until death from any cause
Time frame: From the date of enrolment until death from any cause (approximately 25-30 months after the enrolment of the first patient)
Disease control rate (DCR) by investigator assessment (according to RECIST v1.1)
Defined as the rate of patients, among all enrolled patients, that achieve a complete response (CR) or partial response (PR) or stabilisation of disease (SD, at least at week 6) by investigator assessment
Time frame: approximately 25-30 months after the enrolment of the first patient
Adverse events according to CTCAE v5.0
Adverse events according to CTCAE v5.0 (any-cause as well as treatment-related) including adverse events leading to dose interruptions, withdrawal of protocol treatment and death
Time frame: From the date of enrolment until last patient last visit (approximately 25- 30 months after enrolment of the first patient)
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