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JOURNAL ONKOLOGIE – STUDIE
RAISE

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

Rekrutierend

NCT-Nummer:
NCT05718323

Studienbeginn:
Dezember 2023

Letztes Update:
05.04.2024

Wirkstoff:
Niraparib

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
ETOP IBCSG Partners Foundation

Collaborator:
GlaxoSmithKline, Development Limited,

Studienleiter

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

Kontakt

Studienlocations
(3 von 20)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Angelo Delmonte
E-Mail: angelo.delmonte@irst.emr.it» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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



Secondary outcome:

1. 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

2. 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

3. 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

4. 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

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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