RecruitingPhase 2NCT07019675

A Study of SKB518 in Patients With Lung Cancer

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer


Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Enrollment

192 participants

Start Date

Aug 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 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 SKB518 in adults with lung cancer — either non-small cell or small cell lung cancer — to assess how safe it is and whether it can shrink tumors. **You may be eligible if...** - You are between 18 and 75 years old - You have histologically confirmed non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) - You have at least one measurable tumor - You are generally well enough to carry out daily activities (ECOG 0–1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have uncontrolled heart disease - You have had a history of lung inflammation (pneumonitis or interstitial lung disease) requiring steroids - You require ongoing steroid therapy for another condition - You have active brain metastases that are not treated or stable 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

DRUGSKB518

SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

DRUGTislelizumab

Tislelizumab is administered every 3 weeks(200 mg, Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

DRUGCarboplatin

Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles


Locations(17)

Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Cancer Hospital Chinese Academy of Medical Science

Beijing, China

Shanghai Pulmonary Hospital (Affiliated to Tongji University)

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT07019675


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