RecruitingPhase 2NCT05718323

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.


Sponsor

ETOP IBCSG Partners Foundation

Enrollment

44 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the PARP inhibitor niraparib (a drug that blocks cancer cells from repairing their DNA) to standard immunotherapy maintenance can improve outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC) whose tumors show high levels of a protein called SLFN11 — which may predict a better response to this combination. **You may be eligible if...** - You have confirmed extensive-stage small cell lung cancer (Stage IV) - Your tumor shows high expression of the SLFN11 protein (assessed by a central laboratory) - You completed 4 cycles of standard first-line chemo-immunotherapy (platinum/etoposide + atezolizumab or durvalumab) without disease progression - You are in reasonably good health (ECOG score 0-2) and are 18 or older **You may NOT be eligible if...** - Your cancer is progressing - You have active brain metastases causing symptoms - You have another active cancer - You have significant kidney, liver, or blood count abnormalities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNiraparib

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


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

Hospital Universitario Puerta de Hierro

Madrid, Spain

Kantonsspital Baden

Baden, Switzerland

University Hospital Basel

Basel, Switzerland

Inselspital Bern

Bern, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Centre Hospitalier du Valais Romand

Sion, Switzerland

Bürgerspital Solothurn

Solothurn, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05718323


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