Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%
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 pa
| Condition(s) | NSCLC (Non-small Cell Lung Cancer) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 1.Voluntary participation and informed consent: Subjects must voluntarily join the study, sign the written informed consent form (ICF), and demonstrate good compliance. 2.Age and Gender: Aged ≥65 years at the time of signing the ICF, regardless of gender. 3.Diagnosis and Staging: Histologically or cytologically confirmed Stage IIIB (ineligible for definitive chemoradiotherapy), Stage IIIC, or Stage IV NSCLC according to the AJCC 8th edition staging system. 4.PD-L1 Expression: Tumor tissue confirmed as PD-L1 TPS≥50% by a central laboratory or a validated local laboratory, using SP263 or 22C3 assays (a formal test report must be provided). 5.Driver Gene Status: Known absence of actionable driver mutations, including but not limited to EGFR sensitive mutations, ALK fusio |
| Ages | 65 Years |
| Sex | All |
| Lead sponsor | Tang-Du Hospital |
| Locations | Xi'an, Shannxi, China |
| Start date | 2026-05-13 |
| NCT ID | NCT07596121 |
| Official listing | https://clinicaltrials.gov/study/NCT07596121 |