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

Sponsor
Tang-Du Hospital
Study ID
NCT07596121
Phase
PHASE2
Status
Recruiting
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Conditions

  • NSCLC (Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 13, 2026
Status verified
May 2026
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Serplulimab Monotherapy

Primary Outcome Measure

Progression-free survival [ Time Frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years ]

Central Contacts

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