drugset / Trial / NCT07596121

Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%

NCT07596121

Phase 2 Recruiting 60 enrolled Tang-Du Hospital
NaSingle-groupOpen-labelTreatment

Summary

This prospective clinical study aims to evaluate and observe the efficacy and safety of Serplulimab Monotherapy in Elderly Patients with NSCLC and PD-L1 TPS ≥ 50% using a multicenter, single-arm, phase II design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in May 2026, and recruitment is expected to conclude around May 2026, with the trial anticipated to end by May 2027. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.

Timeline

Start
2026-05-13
Primary completion
2026-05-31
Completion
2027-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Serplulimab Monoclonal antibody 300 mg Intravenous