Serplulimab Monotherapy in Elderly NSCLC Patients with High PD-L1 (≥50%)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm phase II trial evaluating the safety and activity of serplulimab as a standalone treatment in older patients with advanced NSCLC and PD-L1 expression of 50% or higher. Eligible participants are at least 65 years old and have measurable disease, no actionable driver mutations, and PD-L1 TPS ≥50%. Treatment continues until radiographic progression or until stopping criteria are met, with enrollment planned for about 60 patients in Shaanxi Province, China. The study is led by Tang-Du Hospital and aims to provide data on efficacy and tolerability in an elderly, PD-L1 expressive NSCLC population.

Why it matters

Who can join: the full rules

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 fusions, and ROS1 fusions.

  6.Measurable Disease: At least one measurable target lesion per RECIST v1.1 criteria (lesions must not have received prior radiotherapy).

  7.Prior Treatment History: No prior systemic therapy for advanced or metastatic disease. For patients who received adjuvant or neoadjuvant chemotherapy, inclusion is permitted if disease recurrence occurred ≥6 months after the completion of the last dose.

  8.Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2.

  9.Adequate organ and bone marrow function (no blood transfusions or hematopoietic stimulating factor therapy within 14 days prior to the first dose):
  * Absolute Neutrophil Count (ANC)≥1.5 x 10\^9//L
  * Platelet Count (PLT)≥100 x 10\^9//L
  * Hemoglobin (Hb)≥90 g/L
  * Serum Creatinine (Cr) ≤ 1.5 x Limit of Normal (ULN) or Creatinine Clearance ≥ 50mL/min
  * Total Bilirubin (TBIL) ≤ 1.5 x ULN
  * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)≤ 2.5 x ULN(≤ 5 x ULN for patients with liver metastases)

Exclusion Criteria:

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

  2\. Prior Immunotherapy: Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitors (ICIs).

  3\. Autoimmune Disease: Active autoimmune disease requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted.

  4\. Lung Disease/Pneumonitis: Active interstitial lung disease (ILD) or pneumonitis, or a history of (non-infectious) pneumonitis requiring steroid treatment.

  5\. Infections: Active infection requiring systemic therapy. 6. CNS Metastases: Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. However, patients with treated (via surgery or radiotherapy) and stable brain metastases are eligible, provided they are radiographically stable for at least 4 weeks prior to the first dose, have no evidence of new or enlarged brain lesions, and have discontinued glucocorticoids for at least 14 days.

  7\. Pregnancy and Breastfeeding: Pregnant or breastfeeding women. 8. Investigator Discretion: Any other condition that, in the investigator's opinion, may interfere with the evaluation of the study drug, jeopardize subject safety, or confound the interpretation of study results.

Where it's running

• Tangdu Hospital Affiliated to the Fourth Military Medical University
  Xi'an, Shannxi, China Recruiting

Study contacts

• Study coordinator: Lei Pan, Dr
• Email: panlei@fmmu.edu.cn
• Phone: 13991161903

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.