ETOP 23-22 RAISE: A clinical study investigating the effect of Niraparib and immunotherapy in patients with SLFN11-positive small cell lung cancer

ID di studio ICTRP
NCT05718323 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
non disponibile

Titolo accademico
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. (ICTRP)

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

Malattie studiate
SCLC,Extensive Stage;SLFN11-positive (ICTRP)

Intervento studiato
Drug: Niraparib (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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. (ICTRP)

non disponibile

Endpoint primari e secondari
Progression-free survival (PFS) rate at 3 months by investigator assessment (according to RECIST v1.1) (ICTRP)

Progression-free survival (PFS);Overall survival (OS);Disease control rate (DCR) by investigator assessment (according to RECIST v1.1);Adverse events according to CTCAE v5.0 (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
GlaxoSmithKline;Development Limited (ICTRP)

Contatti aggiuntivi
Markus Joerger, MD-PhD;Heidi Roschitzki, PhD, heidi.roschitzki@etop.ibcsg.org, +41 31 511 94 00, Department of Medical Oncology, Cantonal Hospital St.Gallen, (ICTRP)

ID secondari
ETOP 23-22 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05718323 (ICTRP)