SKB518 treatment for people with lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, multicenter phase II trial testing SKB518 monotherapy in adults with histologically confirmed non‑small cell or small cell lung cancer who have at least one measurable lesion and ECOG performance status 0–1. Eligible participants receive SKB518 until radiographic disease progression, intolerable toxicity, withdrawal, or other protocol‑specified discontinuation. The study is focused on safety, tolerability, and preliminary anti‑tumor activity using RECIST v1.1 for response evaluation. Although tislelizumab and carboplatin are listed among interventions, the protocol specifies SKB518 as monotherapy for enrolled subjects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.
2. Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology.
3. At least one measurable tumor lesion per RECIST v1.1.
4. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
5. Expected survival period ≥ 12 weeks.
6. The function of important organs meets the requirements of the protocol.

Exclusion Criteria:

1. Symptomatic or uncontrolled cardiovascular disease
2. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
3. 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.
4. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
5. 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.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
  Shenzhen, Guangdong, China Recruiting
• Cancer Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Hubei Cancer Hospital
  Wuhan, Hubei, China Recruiting
• Renmin Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• Xiangyang Central Hospital
  Xiangyang, Hubei, China Recruiting

Study contacts

• Study coordinator: Xin Li
• Email: lixin@kelun.com
• Phone: 086-010-58202512

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.