NCT07064876

Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer

A Single-Arm, Phase II Clinical Study of Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Xi Junjie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if serplulimab combined with cryoablation can effectively treat early-stage non-small cell lung cancer (NSCLC) in adults who are not eligible for or decline surgery or radiotherapy. The main questions it aims to answer are: What is the objective response rate (ORR) after combination treatment with serplulimab and cryoablation? What are the progression-free survival (PFS), overall survival (OS), 1-year OS rate, and safety outcomes? This is a single-arm, phase II study with no comparison group. Participants will: Receive cryoablation under CT guidance to locally ablate the tumor Receive intravenous serplulimab (300 mg every 3 weeks) for up to 6 cycles Undergo regular imaging and laboratory tests to assess response and monitor safety Provide blood and tissue samples for optional biomarker research The study will enroll 25 patients with stage Ia NSCLC (tumor size \>1 cm and ≤3 cm, no ground-glass opacity, EGFR/ALK/ROS1 wild-type) and aims to explore the potential of combining local and systemic immunotherapy in non-surgical candidates.

Conditions

• Early Lung Cancer

Interventions

Type	Name	Description
DRUG	Serplulimab	PD-1 inhibitor, 300 mg intravenous infusion, once every 3 weeks (Q3W) for up to 6 cycles, starting after cryoablation recovery and in the absence of major procedural complications.
PROCEDURE	CT-guided Cryoablation	Percutaneous cryoablation performed under CT guidance to achieve local tumor ablation. Procedure done once (per-protocol) prior to systemic therapy.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-01
• Completion: 2027-09-01
• First posted: 2025-07-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: China