Actively Recruiting
A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety 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
34 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary anti-tumor effects of SKB518 in patients with lung cancer. This open-label, multicenter phase II study includes patients with non-small cell lung cancer or small cell lung cancer who have measurable tumors. The study aims to better understand how SKB518 works alone or in combination with other drugs in this patient population. Participants receive SKB518 alone or combined with Tislelizumab or Tislelizumab plus Carboplatin. SKB518 and Tislelizumab are given every three weeks until the cancer progresses, unacceptable side effects occur, or other reasons require stopping treatment. Carboplatin is administered every three weeks for four cycles when given. The study has different treatment arms depending on lung cancer type and prior therapy. During the study, participants undergo regular assessments including imaging to check tumor response, safety monitoring for side effects, and evaluations of progression-free survival and overall survival. Researchers also study pharmacokinetics and immune response. The study lasts up to 24 months to observe treatment effects and safety over time.
CONDITIONS
Brief 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 at the time of informed consent, both males and females
- Confirmed non-small cell lung cancer or small cell lung cancer 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 12 weeks or longer
- Adequate function of important organs as required by the protocol
You will not qualify if you...
- Symptomatic or uncontrolled cardiovascular disease
- History of noninfectious pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/ILD
- Need for systemic corticosteroid therapy (>10 mg prednisolone or equivalent) or immunosuppressive therapy within 14 days before first dose
- HIV positive or history of AIDS; active syphilis infection
- Other conditions judged by investigator to interfere with study evaluation, subject safety, or data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until radiographic disease progression, intolerable toxicity, or other discontinuation criteria
Participants receive SKB518 alone or in combination with Tislelizumab and/or Carboplatin. SKB518 and Tislelizumab are administered every 3 weeks until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria. Carboplatin is given every 3 weeks for 4 cycles.
Every 3 weeks visits corresponding to drug administration
Trial Site Locations
Total: 17 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
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2
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
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3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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4
Hubei Cancer Hospital
Wuhan, Hubei, China
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5
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
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6
Xiangyang Central Hospital
Xiangyang, Hubei, China
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7
Hunan Cancer Hospital
Changsha, Hunan, China
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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
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12
Yunnan Cancer Hospital
Kunming, Yunnan, China
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13
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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14
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
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15
Cancer Hospital Chinese Academy of Medical Science
Beijing, China
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16
Shanghai Pulmonary Hospital (Affiliated to Tongji University)
Shanghai, China
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17
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
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Research Team
X
Xin Li
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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