RecruitingPhase 2NCT07230405

A Phase II Study of SKB571 in Patients With Lung Cancer

A Phase II Study to Evaluate the Safety and Efficacy of SKB571 in Patients With Advanced Non-small Cell Lung Cancer

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Enrollment

190 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

Lung Cancer (Non-Small Cell)

Summary

This is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SKB571 in people with advanced non-small cell lung cancer (NSCLC). Researchers want to find out how safe and effective it is at different stages of treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced or metastatic non-small cell lung cancer confirmed by biopsy - You have at least one measurable tumor - You are in good overall health (ECOG score 0 or 1) - Your doctors estimate you will survive at least 12 weeks - Your kidneys, liver, and blood counts are functioning adequately **You may NOT be eligible if...** - You are under 18 or over 75 years old - You have active, uncontrolled brain metastases - You have severe heart, liver, or kidney disease - You are pregnant or breastfeeding - Certain prior treatments may make you ineligible — your doctor will assess this 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

DRUGSKB571 for injection

SKB571 for injection is administered every 3 weeks(Q3W) until radiographic disease progression,intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.