Actively Recruiting
A Study of SKB518 in Patients With Lung Cancer
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
192
Participants Needed
17
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SKB518 in Patients With Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old at the time of signing the informed consent form
- Diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) confirmed by histology or cytology
- At least one measurable tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Adequate function of important organs as required by the study protocol
You will not qualify if you...
- Symptomatic or uncontrolled cardiovascular disease
- History of noninfectious pneumonitis or interstitial lung disease (ILD) requiring steroids, or current pneumonitis/ILD
- Use of systemic corticosteroid therapy (prednisolone >10 mg/day or equivalent) or other immunosuppressive therapy within 14 days before first dose
- Positive for human immunodeficiency virus (HIV) or history of AIDS; active syphilis infection
- Other conditions deemed by the Investigator to interfere with study evaluation, safety, or interpretation of results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
Actively Recruiting
2
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
4
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
5
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
6
Xiangyang Central Hospital
Xiangyang, Hubei, China
Actively Recruiting
7
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
8
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
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9
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
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10
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
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11
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Actively Recruiting
12
Yunnan Cancer Hospital
Kunming, Yunnan, China
Actively Recruiting
13
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
14
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Actively Recruiting
15
Cancer Hospital Chinese Academy of Medical Science
Beijing, China
Actively Recruiting
16
Shanghai Pulmonary Hospital (Affiliated to Tongji University)
Shanghai, China
Actively Recruiting
17
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
X
Xin Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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