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.
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.
• 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.
• 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.