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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China
RECRUITINGProgression-free survival
Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years
Overall Survival
Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause)
Time frame: The maximum time from receiving treatment to dying for any reason is 4 years.
Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Disease Control Rate
Disease Control Rate (DCR) is defined as the percentage of participants who achieved a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Disease Control Rate (DCR) is analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
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