Phase II Study of Adding Niraparib to Anti-PD-L1 Antibody Maintenance for Patients With SLFN11-positive Extensive-stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the addition of niraparib to anti-PD-L1 antibody maintenance treatment in patients with SLFN11-positive extensive-disease small cell lung cancer ED-SCLC that has not progressed after standard first-line chemo-immunotherapy. This international, multicenter, single-arm phase II trial aims to assess the clinical effectiveness of this combined treatment approach. The treatment involves giving niraparib orally at a dose of 200 mg once daily, which may be increased to 300 mg daily for patients with body weight 77 kg or higher and platelet counts of at least 150 gL, continuing until disease progression. This is combined with ongoing anti-PD-L1 antibody maintenance therapy following initial chemo-immunotherapy. The trial includes a screening phase for SLFN11 expression in tumor tissue and treatment continues as long as patients meet criteria and tolerate therapy. Participants will be closely monitored with tumor assessments following RECIST v1.1 criteria, tracking progression-free survival at 3 months as the primary outcome. Secondary outcomes include longer-term progression-free survival, overall survival, disease control rate, and adverse events according to CTCAE version 5.0. The total observation period extends approximately 25 to 30 months after the first patient enrollment. Safety and treatment adherence are also evaluated throughout this period.

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