Loading clinical trials...

Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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.

NCT05718323•ETOP IBCSG Partners Foundation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 according to the 8th TNM classification).
•Availability of FFPE tumour tissue for screening.
•Written IC part 2: for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention.
•High SLFN11-expression on FFPE tumour material:
•SLFN11-expression is determined at the central screening laboratory in Basel. Overexpression is defined as detectable protein expression by IHC in ≥20% of tumour cells.
•Patients must have received standard first-line chemo-immunotherapy, consisting of 4 cycles of platinum-etoposide chemotherapy in combination with an anti-PD-L1 antibody (atezolizumab or durvalumab). Patients who started the immunotherapy at chemotherapy cycle 2 are eligible.
•ED-SCLC must not have progressed during or after standard chemo-immunotherapy (as per RECIST v1.1).
•Patients must be candidates for ongoing maintenance treatment with immune-checkpoint inhibition.
•Adequate haematological function:
+5 more criteria

Exclusion Criteria

•Symptomatic brain metastases
•Any clinically active cancer, other than SCLC Exception: malignancies with negligible risk of metastases or death (e.g. 5-year OS rate of \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. Hormonal therapy for non-metastatic prostate or ductal carcinoma in situ is allowed.
•Consolidating thoracic radiotherapy. Palliative radiotherapy to the brain or to bones is allowed.
•History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
•Any lung disease requiring systemic steroids in doses of \>10 mg prednisolone (or equivalent dose of other steroid).
•Any serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator would compromise the patient's ability to complete the trial or interfere with the evaluation of the efficacy and safety of the protocol treatment.
•Inadequately controlled hypertension, defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>95 mmHg.
•The patient must be considered stable and hypertension medically controlled.
•History of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML).
•Prior Reversible Encephalopathy Syndrome (PRES)
+7 more criteria

Locations (18)

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

Complejo Hospitalario de Jaén

Jaén, Spain

Key Dates

Start Date

December 20, 2023

Primary Completion Date

December 1, 2026

Completion Date

June 1, 2027

Last Updated

February 6, 2026

Enrollment

ESTIMATED participants

Conditions

SCLC,Extensive StageSLFN11-positive

Interventions

Niraparib

DRUG

Contacts

Heidi Roschitzki, PhD

CONTACT

+41 31 511 94 00 heidi.roschitzki@etop.ibcsg.org

Susanne Roux

CONTACT

RAISE@etop.ibcsg.org

A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy Progression

NCT07289048

SCLC,Extensive Stage

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions