SCLC,Extensive StagePhase 2RAISENCT05718323
Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC
A Phase 2 study testing Niraparib in people with SCLC,Extensive Stage and SLFN11-positive, run by ETOP IBCSG Partners Foundation at 18 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC,Extensive Stage, SLFN11-positive
- What is being tested?
- Niraparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 20 Dec 2023to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
18 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Susanne Roux contact
18 sites in 5 countries
Switzerland7 sites, 7 recruiting
- Recruiting
Kantonsspital Baden
Baden
Christine Waibel, christine.waibel@ksb.ch
- Recruiting
University Hospital Basel
Basel
David König, david.koenig@usb.ch
- Recruiting
Inselspital Bern
Bern
Ferdinando Cerciello, ferdinando.cerciello@insel.ch
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen
Markus Jörger, markus.Joerger@kssg.ch
- Recruiting
Centre Hospitalier du Valais Romand
Sion
Alexandre Huber, Alexandre.Huber@hopitalvs.ch
- Recruiting
Bürgerspital Solothurn
Solothurn
Amina Scherz, amina.scherz@spital.so.ch
- Recruiting
Kantonsspital Winterthur
Winterthur
Laetitia Mauti, laetitia.mauti@ksw.ch
France4 sites, 4 recruiting
- Recruiting
CHU - Angers
Angers
Youssef Oulkohuir, youssef.oulkhouir@chu-angers.fr
- Recruiting
Centre Hospitalier d'Avignon
Avignon
Nicolas Cloarec, CLOAREC.Nicolas@ch-avignon.fr
- Recruiting
Caen - CHU
Caen
Simon Deshayes, deshayes-si@chu-caen.fr
- Not yet recruiting
Lyon - Centre Léon Bérard
Lyon
Maurice Pérol, maurice.perol@lyon.unicancer.fr
Italy3 sites, 3 recruiting
- Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola
Angelo Delmonte, angelo.delmonte@irst.emr.it
- Not yet recruiting
Instituto Europeo di Oncologia (IEO)
Milan
Antonio Passaro, Antonio.Passaro@ieo.it
- Recruiting
Santa Maria della Misericordia Hospital
Perugia
Giulio Metro, giulio.metro@ospedale.perugia.it
Spain3 sites, 3 recruiting
- Not yet recruiting
Complejo Hospitalario Universitario a Coruña
A Coruña
Rosario Garcia Campelo
- Recruiting
Complejo Hospitalario de Jaén
Jaén
Ana Laura Ortega Granados
- Recruiting
Hospital Universitario Puerta de Hierro
Madrid
Mariano Provencio
Germany1 site, 1 recruiting
- Recruiting
LMU Klinikum / Thoracic Oncology center Münich
München
Diego Kauffmann-Guerrero
About this study
Official title: 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.
- Conditions
- SCLC,Extensive Stage, SLFN11-positive
- Being tested
- Niraparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
200 mg orally once daily, until PD 300 mg once daily if body weight ≥77 kg and platelets ≥150 g/L, until PD
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From date of enrolment until 3 months post-enrolment
Secondary outcomes (4)
Progression-free survival (PFS)
Defined as the time from the date of enrolment until documented progression
Measured: From the date of enrolment until last tumour assessment (approximately 25-30 months after the enrolment of the first patient)
Overall survival (OS)
Defined as the time from the date of enrolment until death from any cause
Measured: 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)
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
Measured: approximately 25-30 months after the enrolment of the first patient
Adverse events according to CTCAE v5.0
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
Measured: From the date of enrolment until last patient last visit (approximately 25- 30 months after enrolment of the first patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start20 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC,Extensive StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Sponsor type
- Research network
- Collaborators
- GlaxoSmithKline, Development Limited
- Responsible party
- Sponsor
- Investigators
- Markus Joerger, MD-PhD, Study chair, Department of Medical Oncology, Cantonal Hospital St.Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718323
- Sponsor's protocol ID
- ETOP 23-22
- Acronym
- RAISE
- Status last verified
- May 2026
- First submitted
- 30 Jan 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05718323
- Acronym / sponsor ID
- RAISE / ETOP 23-22
- Conditions
- SCLC,Extensive Stage, SLFN11-positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- ETOP IBCSG Partners FoundationResearch network
- Collaborators
- GlaxoSmithKline, Development Limited
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Niraparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niraparib200 mg orally once daily, until PD 300 mg once daily if body weight ≥77 kg and platelets ≥150 g/L, until PD | Drug | Treatment Arm |
Primary outcome
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
4 secondary outcomes
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)
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)
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes
Related trials for SCLC,Extensive Stage
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanne Roux contact
Markus Joerger, MD-PhD study chair
Department of Medical Oncology, Cantonal Hospital St.Gallen
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niraparib in people with SCLC,Extensive Stage and SLFN11-positive, run by ETOP IBCSG Partners Foundation at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Switzerland, France, Italy, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Roschitzki, PhD (+41 31 511 94 00, heidi.roschitzki@etop.ibcsg.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.