NCT06195683

Serplulimab for Patients With Non-small Cell Lung Cancer (NSCLC) With TPS ≥ 50%: a Prospective, Single-center, Single-arm Phase 2 Study.

Prospective, Single-center, Single-arm Phase 2 Clinical Study on the Efficacy and Safety of Single-agent Neoadjuvant Therapy With Serplulimab in Patients With Non-small Cell Lung Cancer With TPS ≥ 50%.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to observe the efficacy and safety of Serplulimab monotherapy as a neoadjuvant treatment for TPS ≥ 50% non-small cell lung cancer (NSCLC).

Detailed description

The study aims to explore new strategies for neoadjuvant treatment of resectable NSCLC patients with TPS ≥ 50%, and to identify potential prognostic biomarkers. Participants with stage ⅠB-ⅢA and TPS ≥ 50% non-small cell lung cancer, excluding EGFR and ALK gene mutations will receive 4 cycles of Serplulimab monotherapy at 4.5mg/kg as neoadjuvant treatment before surgery. Subsequently, they will undergo surgical resection and evaluation of the effect of neoadjuvant therapy. 14 cycles of Serplulimab as adjuvant treatment. Participants will provide blood samples before neoadjuvant treatment, before the third cycle of neoadjuvant treatment, before surgery, and 4-7 days after surgery for Minimal Residual Disease（MRD） detection to assist in evaluating the treatment effect.

Conditions

• Non-small Cell Lung Cancer
• PDL1 Gene Mutation

Interventions

Type	Name	Description
DRUG	Serplulimab	Serplulimab for 4.5mg/kg IV Q3W day 1,22,43,64

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-31
• Completion: 2025-06-20
• First posted: 2024-01-08
• Last updated: 2024-01-08

Locations

1 site across 1 country: China