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

Sponsor
Xi Junjie
Study ID
NCT07064876
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Early Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    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.
  • CT-guided Cryoablation — PROCEDURE
    Percutaneous cryoablation performed under CT guidance to achieve local tumor ablation. Procedure done once (per-protocol) prior to systemic therapy.

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Oct 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Serplulimab + Cryoablation
    Participants in this arm will receive serplulimab combined with CT-guided cryoablation for the treatment of early-stage, inoperable non-small cell lung cancer (NSCLC). Cryoablation will be performed first to locally ablate the tumor. Following recovery, participants will receive intravenous serplulimab at a dose of 300 mg every 3 weeks for up to 6 cycles, starting as soon as no major post-procedural complications are observed. The combination therapy aims to evaluate efficacy (objective response rate) and safety, as well as explore potential biomarkers predictive of treatment outcomes.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 12 months ]

Central Contacts