Trial Title:
Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC
NCT ID:
NCT05718323
Condition:
SCLC,Extensive Stage
SLFN11-positive
Conditions: Official terms:
Niraparib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Niraparib
Description:
200 mg orally once daily, until PD 300 mg once daily if body weight ≥77 kg and platelets
≥150 g/L, until PD
Arm group label:
Treatment Arm
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU - Angers
Address:
City:
Angers
Country:
France
Status:
Recruiting
Contact:
Last name:
Youssef Oulkohuir
Email:
youssef.oulkhouir@chu-angers.fr
Facility:
Name:
Centre Hospitalier d'Avignon
Address:
City:
Avignon
Country:
France
Status:
Recruiting
Contact:
Last name:
Nicolas Cloarec
Email:
CLOAREC.Nicolas@ch-avignon.fr
Facility:
Name:
Caen - CHU
Address:
City:
Caen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Simon Deshayes
Email:
deshayes-si@chu-caen.fr
Facility:
Name:
Lyon - Centre Léon Bérard
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Maurice Pérol
Email:
maurice.perol@lyon.unicancer.fr
Facility:
Name:
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Address:
City:
Meldola
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Angelo Delmonte
Email:
angelo.delmonte@irst.emr.it
Facility:
Name:
Instituto Europeo di Oncologia (IEO)
Address:
City:
Milan
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Antonio Passaro
Email:
Antonio.Passaro@ieo.it
Facility:
Name:
Santa Maria della Misericordia Hospital
Address:
City:
Perugia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Giulio Metro
Email:
giulio.metro@ospedale.perugia.it
Facility:
Name:
AULSS2 Marca Trevigiana Treviso
Address:
City:
Treviso
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Adolfo Favaretto
Email:
adolfo.favaretto@aulss2.veneto.it
Facility:
Name:
Medisprof Cancer Center
Address:
City:
Cluj-Napoca
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Adrian Udrea
Email:
adrianudrea@medisprof.ro
Facility:
Name:
Complejo Hospitalario Universitario a Coruña
Address:
City:
A Coruña
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Rosario Garcia Campelo
Facility:
Name:
Complejo Hospitalario de Jaén
Address:
City:
Jaén
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ana Laura Ortega Granados
Facility:
Name:
Hospital Universitario Puerta de Hierro
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Mariano Provencio
Facility:
Name:
Kantonsspital Baden
Address:
City:
Baden
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Christine Waibel
Email:
christine.waibel@ksb.ch
Facility:
Name:
University Hospital Basel
Address:
City:
Basel
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
David König
Email:
david.koenig@usb.ch
Facility:
Name:
Inselspital Bern
Address:
City:
Bern
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Ferdinando Cerciello
Email:
ferdinando.cerciello@insel.ch
Facility:
Name:
Kantonsspital St. Gallen
Address:
City:
Saint Gallen
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Markus Jörger
Email:
markus.Joerger@kssg.ch
Facility:
Name:
Centre Hospitalier du Valais Romand
Address:
City:
Sion
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Alexandre Huber
Email:
Alexandre.Huber@hopitalvs.ch
Facility:
Name:
Bürgerspital Solothurn
Address:
City:
Solothurn
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Amina Scherz
Email:
amina.scherz@spital.so.ch
Facility:
Name:
Kantonsspital Winterthur
Address:
City:
Winterthur
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Laetitia Mauti
Email:
laetitia.mauti@ksw.ch
Start date:
December 20, 2023
Completion date:
October 2025
Lead sponsor:
Agency:
ETOP IBCSG Partners Foundation
Agency class:
Other
Collaborator:
Agency:
GlaxoSmithKline
Agency class:
Industry
Collaborator:
Agency:
Development Limited
Agency class:
Other
Source:
ETOP IBCSG Partners Foundation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05718323
