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

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Trial Identification

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

Official Title: 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%.

Study ID: NCT06195683

Interventions

Serplulimab

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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