RecruitingPhase 2NCT07596121

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

Multicenter, Single-arm, Phase II Exploratory Study of Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%

Sponsor

Tang-Du Hospital

Enrollment

60 participants

Start Date

May 13, 2026

Study Type

INTERVENTIONAL

Conditions

NSCLC (Non-small Cell Lung Cancer)

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Serplulimab for people with nsclc (non-small cell lung cancer). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSerplulimab

The treatment follows a 21-day (3-week) cycle. Serplulimab is administered intravenously at a fixed dose of 300 mg on Day 1 of each cycle (Q3W). Prior to each administration, subjects shall undergo comprehensive clinical assessments-including vital signs, anthropometric measurements, physical examinations, laboratory monitoring, and ECOG performance status (PS)-to confirm safety and tolerability for continued treatment.