Tests SKB518 in adults with lung cancer
Tests the drug SKB518 in adults with lung cancer for safety and anti-tumor effect.
Key facts
- Who runs it
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Where
- Beijing, Changsha, Hangzhou, Jinan, Kunming, Nanchang, Nanning, Shanghai, Shenzhen, Taiyuan, Taizhou, Tianjin, Ürümqi, Wuhan, Xiangyang, and Zhengzhou, ChinaSee the 17 sites
- Trial code
- Registry title
- A Study of SKB518 in Patients With Lung Cancer
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 192 people, planned
- Started
- 29 Aug 2025
- Expected to end
- 20 Oct 2027
- Type of study
- Interventional, 3 groups
- Treatments tested
- SKB518
- Tislelizumab
- Carboplatin
- Record updated
- 8 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with non-small cell or small cell lung cancer, confirmed by a lab test of tissue or cells. People receive SKB518 until the cancer grows, side effects are too severe, or other stopping rules apply.
- Age
- 18 to 75 years
- Sex
- Men and women
- Disease stage
- Non-small cell lung cancer or small cell lung cancer, confirmed by histology or cytology. At least one tumour lesion that can be measured (RECIST v1.1).
- Earlier treatment
- Not stated in the record. No systemic corticosteroids above 10 mg/d (prednisolone or equivalent) or other immunosuppressive therapy within 14 days before the first dose.
Main reasons for not taking part
- Cardiovascular disease with symptoms or not under control
- Past non-infectious pneumonitis or interstitial lung disease that needed steroids, or current pneumonitis or interstitial lung disease
- Disease needing systemic corticosteroids above 10 mg/d or other immunosuppressive treatment within 14 days before the first dose
- HIV-positive, history of AIDS, or known active syphilis
- Any other situation the investigator thinks would interfere with the study or the person's safety
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females
- Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology
- At least one measurable tumor lesion per RECIST v1.1
- Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale
- Expected survival period ≥ 12 weeks
- The function of important organs meets the requirements of the protocol
Who cannot take part
- Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of >10 mg/d) or other immunosuppressive therapy within 14 days before the first dose
- Symptomatic or uncontrolled cardiovascular disease
- History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
- Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection
- The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Cancer Hospital Chinese Academy of Medical ScienceBeijing, ChinaContact: Jie WangTaking people
- Hunan Cancer HospitalChangsha, ChinaContact: Hui WangTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaContact: Yun FanTaking people
- Cancer Hospital of Shandong First Medical UniversityJinan, ChinaContact: Xiangjiao MengTaking people
- Yunnan Cancer HospitalKunming, ChinaContact: Runxiang YangTaking people
- Jiangxi Cancer HospitalNanchang, ChinaContact: Hui LuoTaking people
- Cancer Hospital of Guangxi Medical UniversityNanning, ChinaContact: Wenhua ZhaoTaking people
- Shanghai Pulmonary Hospital Affiliated to Tongji UniversityShanghai, ChinaContact: Yayi HeTaking people
- Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen CenterShenzhen, ChinaContact: Shi JinTaking people
- Shanxi Cancer hospitalTaiyuan, ChinaContact: Qinxiang GuoTaking people
- Taizhou Hospital of Zhejiang ProvinceTaizhou, ChinaContact: Dongqing LvTaking people
- Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaContact: Peng ChenTaking people
- Affiliated Cancer Hospital of Xinjiang Medical UniversityÜrümqi, ChinaContact: Chunlin LiuTaking people
- Hubei Cancer HospitalWuhan, ChinaContact: Bin YangTaking people
- Renmin Hospital of Wuhan UniversityWuhan, ChinaContact: Qibin SongTaking people
- Xiangyang Central HospitalXiangyang, ChinaContact: Tienan YiTaking people
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Sanxing GuoTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- 2L+ SCLC or non-Squamous NSCLCTreatment being tested
SKB518 monotherapy
Treatment: SKB518
- 2L SCLCTreatment being tested
SKB518+Tislelizumab or Tislelizumab monotherapy
Treatment: SKB518 and Tislelizumab
- 1L ES-SCLCTreatment being tested
SKB518+Tislelizumab+Carboplatin
Treatment: SKB518, Tislelizumab, and Carboplatin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer
- Plain-language title
- Tests SKB518 in adults with lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07019675, who can take part
- Record updated
- 8 May 2026