Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC

Recruiting Phase 2 Interventional Study
SCLC,Extensive Stage SLFN11-positive
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
ETOP IBCSG Partners Foundation · Research network
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About This Trial
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 pr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Inclusion criteria for SLFN11-expression testing * Written IC part 1: for SLFN11-screening must be signed and dated by the patient and the investigator prior to sending any tumour material to the central laboratory. * Histologically or cytologically confirmed ED-SCLC (stage IV …
Contacts

Heidi Roschitzki, PhD

+41 31 511 94 00

heidi.roschitzki@etop.ibcsg.org

CONTACT

Susanne Roux

RAISE@etop.ibcsg.org

CONTACT