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

ConditionsSCLC,Extensive Stage SLFN11-positive

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorETOP IBCSG Partners Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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).

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

44 Participants

are divided into 1 treatment group

Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

From date of enrolment until 3 months post-enrolment

Secondary outcomes

Progression-free survival (PFS)

Defined as the time from the date of enrolment until documented progression

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)

Defined as the time from the date of enrolment until death from any cause

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)

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

Time frame

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

Time frame

From the date of enrolment until last patient last visit (approximately 25- 30 months after enrolment of the first patient)