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

NCT05718323 | Recruiting Phase 2 DMC

• 1 other identifier: ETOP 23-22
• Study Type: interventional
• Target: 44
• Locations: 4 countries
• Sites: 18

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  From date of enrolment until 3 months post-enrolment

Secondary Outcomes (4)

• Progression-free survival (PFS)

  From the date of enrolment until last tumour assessment (approximately 25-30 months after the enrolment of the first patient)

• Overall survival (OS)

  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)

  approximately 25-30 months after the enrolment of the first patient

• Adverse events according to CTCAE v5.0

  From the date of enrolment until last patient last visit (approximately 25- 30 months after enrolment of the first patient)

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Drug: Niraparib

Interventions

Niraparib DRUG

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Adequate renal function:
• Adequate liver function:
• ECOG PS 0-2
• Age ≥18 years
• Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 4 weeks before enrolment and within 3 days before treatment start.

You may not qualify if:

• 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)
• Severe renal or hepatic impairment.
• Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
• Treated with live vaccine within 30 days before enrolment.
• Hypersensitivity to niraparib or any of its excipients (e.g., tartrazine).
• Women who are pregnant or in the period of lactation.

Sponsors & Collaborators

• ETOP IBCSG Partners Foundation: lead
• GlaxoSmithKline: collaborator
• Development Limited: collaborator

Study Sites (18)

CHU - Angers

Angers, France

RECRUITING

Centre Hospitalier d'Avignon

Avignon, France

RECRUITING

Caen - CHU

Caen, France

RECRUITING

Lyon - Centre Léon Bérard

Lyon, France

NOT YET RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, Italy

RECRUITING

Instituto Europeo di Oncologia (IEO)

Milan, Italy

NOT YET RECRUITING

Santa Maria della Misericordia Hospital

Perugia, Italy

RECRUITING

AULSS2 Marca Trevigiana Treviso

Treviso, Italy

NOT YET RECRUITING

Complejo Hospitalario Universitario a Coruña

A Coruña, Spain

NOT YET RECRUITING

Complejo Hospitalario de Jaén

Jaén, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, Spain

RECRUITING

Kantonsspital Baden

Baden, Switzerland

RECRUITING

University Hospital Basel

Basel, Switzerland

RECRUITING

Inselspital Bern

Bern, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

RECRUITING

Centre Hospitalier du Valais Romand

Sion, Switzerland

RECRUITING

Bürgerspital Solothurn

Solothurn, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, Switzerland

RECRUITING

MeSH Terms

Interventions

niraparib

Study Officials

• Markus Joerger, MD-PhD

  Department of Medical Oncology, Cantonal Hospital St.Gallen

  STUDY CHAIR

Central Study Contacts

Heidi Roschitzki, PhD

CONTACT

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

Susanne Roux

CONTACT

RAISE@etop.ibcsg.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

FR (4); ES (3); IT (4); CH (7)