RecruitingPhase 2NCT07120282

Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC

A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

108 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called tislelizumab after surgery can reduce the chance of lung cancer returning in patients with early-stage (Stage I) non-small cell lung cancer (NSCLC) that has specific high-risk features. This type of treatment given after surgery is called adjuvant therapy. **You may be eligible if...** - You are 18 or older with confirmed Stage I NSCLC, with a tumor between 2 cm and 4 cm in size - Your post-surgery pathology shows at least one high-risk feature such as invasion of blood vessels, spread through the air spaces (STAS), poorly differentiated tumor cells, or high-grade adenocarcinoma - You have had complete surgical removal of the tumor - Your overall health and organ function are adequate to receive immunotherapy **You may NOT be eligible if...** - You have Stage II or higher lung cancer - Your tumor is smaller than 2 cm or larger than 4 cm - You have no high-risk pathological features after surgery - You have active autoimmune disease or are on systemic steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group

Tislelizumab 400 mg iv, q6w, for up to 1 year; patients are permitted to receive concurrent adjuvant platinum-based doublet chemotherapy (q3w, up to 4 cycles) starting from the first dose of tislelizumab; during concurrent chemotherapy, a tislelizumab dosage of 200 mg iv, q3w is allowed.


Locations(1)

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, China

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NCT07120282


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