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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT06195683
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    Serplulimab for 4.5mg/kg IV Q3W day 1,22,43,64

Study Details

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).

Key Dates

Start date
Dec 1, 2023
Status verified
Dec 2023
Primary completion
Dec 31, 2024
Completion
Jun 20, 2025

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: anti-PDL-1 Immunotherapy followed by Surgical Resection
    Participants will receive four preoperative doses of PDL-1 inhibitor Serplulimab in adults with untreated, surgically resectable early (stage IB, II, or IIIA) NSCLC. Serplulimab (at a dose of 4.5mg per kilogram of body weight) was administered intravenously every 3 weeks, with surgery planned approximately 4 weeks after the last dose.

Primary Outcome Measure

Pathologic Complete Response Rate, pCR [ Time Frame: Assessed 1 month after surgery ]

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