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 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-asses

Trial Details

NCT ID
NCT07596121
Phase
PHASE2
Sponsor
Tang-Du Hospital
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Serplulimab
Locations (sample)
  • Xi'an, Shannxi, China|34.25833,108.92861

Key Eligibility Criteria

  • Voluntary participation and informed consent: Subjects must voluntarily join the study, sign the written informed consent form (ICF), and demonstra…
  • Age and Gender: Aged ≥65 years at the time of signing the ICF, regardless of gender.
  • Diagnosis and Staging: Histologically or cytologically confirmed Stage IIIB (ineligible for definitive chemoradiotherapy), Stage IIIC, or Stage IV …
  • 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 fo…

For full eligibility, visit ClinicalTrials.gov.

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