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

NCT05718323 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • SCLC,Extensive Stage
  • SLFN11-positive

Interventions

DRUG

Niraparib

200 mg orally once daily, until PD 300 mg once daily if body weight ≥77 kg and platelets ≥150 g/L, until PD

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Development Limited

    collaborator UNKNOWN

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Markus Joerger, MD-PhD · Department of Medical Oncology, Cantonal Hospital St.Gallen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • France
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05718323 on ClinicalTrials.gov