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

May 27, 2026 updated by: ETOP IBCSG Partners Foundation

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
  • Germany
      • München, Germany
        • Recruiting
        • LMU Klinikum / Thoracic Oncology center Münich
        • Contact:
          • Diego Kauffmann-Guerrero
  • Italy
      • Meldola, Italy
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
        • Contact:
      • Milan, Italy
        • Not yet recruiting
        • Instituto Europeo di Oncologia (IEO)
        • Contact:
      • Perugia, Italy
  • Spain
      • A Coruña, Spain
        • Not yet recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
          • Rosario Garcia Campelo
      • Jaén, Spain
        • Recruiting
        • Complejo Hospitalario de Jaén
        • Contact:
          • Ana Laura Ortega Granados
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Puerta De Hierro
        • Contact:
          • Mariano Provencio
  • Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 according to the 8th TNM classification).
  • Availability of FFPE tumour tissue for screening.

Inclusion criteria for trial participation

  • 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.

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)
  • 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.
  • Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial and within the required timelines after last dose of niraparib treatment.
  • Judgment by the investigator that the patient is unlikely to comply with trial procedures, restrictions and requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) rate at 3 months by investigator assessment (according to RECIST v1.1)
Time Frame: From date of enrolment until 3 months post-enrolment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From the date of enrolment until last tumour assessment (approximately 25-30 months after the enrolment of the first patient)
Defined as the time from the date of enrolment until documented progression
From the date of enrolment until last tumour assessment (approximately 25-30 months after the enrolment of the first patient)
Overall survival (OS)
Time Frame: From the date of enrolment until death from any cause (approximately 25-30 months after the enrolment of the first patient)
Defined as the time from the date of enrolment until death from any cause
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)
Time Frame: approximately 25-30 months after the enrolment of the first patient
Defined as the rate of patients, among all enrolled patients, that achieve a complete response (CR) or partial response (PR) or stabilisation of disease (SD, at least at week 6) by investigator assessment
approximately 25-30 months after the enrolment of the first patient
Adverse events according to CTCAE v5.0
Time Frame: From the date of enrolment until last patient last visit (approximately 25- 30 months after enrolment of the first patient)
Adverse events according to CTCAE v5.0 (any-cause as well as treatment-related) including adverse events leading to dose interruptions, withdrawal of protocol treatment and death
From the date of enrolment until last patient last visit (approximately 25- 30 months after enrolment of the first patient)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ETOP IBCSG Partners Foundation

Collaborators

GlaxoSmithKline
Development Limited

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETOP 23-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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