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Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%
Sponsor: Tang-Du Hospital
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.
Official title: Multicenter, Single-arm, Phase II Exploratory Study of Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-05-13
Completion Date
2027-05-31
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
Serplulimab
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.
Locations (1)
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China