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

ConditionNSCLC (Non-small Cell Lung Cancer)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorTang-Du Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

1.Voluntary participation and informed consent: Subjects must voluntarily join the study, sign the written informed consent form (ICF), and demonstrate good compliance.

Absolute Neutrophil Count (ANC)≥1.5 x 10^9//L

Platelet Count (PLT)≥100 x 10^9//L

Hemoglobin (Hb)≥90 g/L

Disqualifiers

1. Hypersensitivity: Known hypersensitivity to serplulimab or any of its excipients.

Trial design

Design model

Single group

Treatments tested in this trial

  • Serplulimab

    Drug

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Serplulimab MonotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-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

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov
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