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NCT07019675RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 8 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
192 (estimated)
First submitted
5 Jun 2025
Start date
29 Aug 2025
Primary completion date
20 Feb 2027
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Diseases
Lung cancer
NCT number
NCT07019675

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 192
  • From 29 Aug 2025 to the primary completion date, 20 Feb 2027
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cancer Hospital Chinese Academy of Medical Science
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BeijingChinaRecruiting
Hunan Cancer Hospital
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ChangshaChinaRecruiting
Zhejiang Cancer Hospital
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HangzhouChinaRecruiting
Cancer Hospital of Shandong First Medical University
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JinanChinaRecruiting
Yunnan Cancer Hospital
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KunmingChinaRecruiting
Jiangxi Cancer Hospital
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NanchangChinaRecruiting
Cancer Hospital of Guangxi Medical University
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NanningChinaRecruiting
Shanghai Pulmonary Hospital Affiliated to Tongji University
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ShanghaiChinaRecruiting
Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center
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ShenzhenChinaRecruiting
Shanxi Cancer hospital
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TaiyuanChinaRecruiting
Taizhou Hospital of Zhejiang Province
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TaizhouChinaRecruiting
Tianjin Medical University Cancer Institute & Hospital
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TianjinChinaRecruiting
Affiliated Cancer Hospital of Xinjiang Medical University
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ÜrümqiChinaRecruiting
Renmin Hospital of Wuhan University
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WuhanChinaRecruiting
Hubei Cancer Hospital
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WuhanChinaRecruiting
Xiangyang Central Hospital
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XiangyangChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.