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
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
Treatments tested in this trial
- Serplulimab
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov