Actively Recruiting
Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC
Led by ETOP IBCSG Partners Foundation · Updated on 2026-02-06
44
Participants Needed
18
Research Sites
179 weeks
Total Duration
On this page
Sponsors
E
ETOP IBCSG Partners Foundation
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent for SLFN11 screening and trial participation prior to interventions
- Histologically or cytologically confirmed extensive-disease small cell lung cancer (stage IV)
- Availability of tumor tissue for SLFN11 expression testing
- High SLFN11 expression defined as protein in 20% or more of tumor cells
- Completed 4 cycles of platinum-etoposide chemotherapy with anti-PD-L1 antibody (atezolizumab or durvalumab)
- Cancer has not progressed during or after standard chemo-immunotherapy
- Candidate for ongoing immune checkpoint maintenance treatment
- Adequate blood, kidney, and liver function
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Age 18 years or older
- Women of childbearing potential must have a negative pregnancy test within 4 weeks before enrollment and within 3 days before treatment start
You will not qualify if you...
- Symptomatic brain metastases
- Any active cancer other than small cell lung cancer, except certain low-risk cancers
- History of lung diseases such as idiopathic pulmonary fibrosis or drug-induced pneumonitis
- Use of systemic steroids above 10 mg prednisolone equivalent
- Serious systemic disorders compromising trial participation
- Uncontrolled hypertension (systolic >150 mmHg or diastolic >95 mmHg)
- History of myelodysplastic syndrome or acute myeloid leukemia
- Prior reversible encephalopathy syndrome
- Severe kidney or liver impairment
- Significant gastrointestinal conditions affecting drug absorption
- Live vaccine within 30 days before enrollment
- Allergy to niraparib or its ingredients
- Pregnant or breastfeeding women
- Sexually active men and women of childbearing potential unwilling to use effective contraception
- Unlikely to comply with trial procedures or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
CHU - Angers
Angers, France
Actively Recruiting
2
Centre Hospitalier d'Avignon
Avignon, France
Actively Recruiting
3
Caen - CHU
Caen, France
Actively Recruiting
4
Lyon - Centre Léon Bérard
Lyon, France
Not Yet Recruiting
5
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, Italy
Actively Recruiting
6
Instituto Europeo di Oncologia (IEO)
Milan, Italy
Not Yet Recruiting
7
Santa Maria della Misericordia Hospital
Perugia, Italy
Actively Recruiting
8
AULSS2 Marca Trevigiana Treviso
Treviso, Italy
Not Yet Recruiting
9
Complejo Hospitalario Universitario a Coruña
A Coruña, Spain
Not Yet Recruiting
10
Complejo Hospitalario de Jaén
Jaén, Spain
Actively Recruiting
11
Hospital Universitario Puerta de Hierro
Madrid, Spain
Actively Recruiting
12
Kantonsspital Baden
Baden, Switzerland
Actively Recruiting
13
University Hospital Basel
Basel, Switzerland
Actively Recruiting
14
Inselspital Bern
Bern, Switzerland
Actively Recruiting
15
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
16
Centre Hospitalier du Valais Romand
Sion, Switzerland
Actively Recruiting
17
Bürgerspital Solothurn
Solothurn, Switzerland
Actively Recruiting
18
Kantonsspital Winterthur
Winterthur, Switzerland
Actively Recruiting
Research Team
H
Heidi Roschitzki, PhD
CONTACT
S
Susanne Roux
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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