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RECRUITING
NCT07019675
PHASE2

A Study of SKB518 in Patients With Lung Cancer

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2025-08-29

Completion Date

2027-10-20

Last Updated

2025-12-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

SKB518

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

DRUG

Tislelizumab

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.

DRUG

Carboplatin

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