A Study of SKB518 in Patients With Lung Cancer

Launched by SICHUAN KELUN PHARMACEUTICAL RESEARCH INSTITUTE CO., LTD. · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called SKB518 for patients with lung cancer. The main goal is to see how safe SKB518 is and how well it works to fight tumors in people whose previous treatments didn’t work. The study will include adult patients aged 18 to 75 who have either non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) that has worsened after standard therapy. To participate, patients need to have at least one tumor that can be measured and a good level of health, which is assessed using a simple performance scale.

Participants in the trial will receive SKB518 as their only treatment until their cancer progresses, they experience side effects that are too severe to continue, or they decide to stop for any reason. It's important to note that this study is not yet recruiting participants, so those interested will need to wait until it starts. Additionally, some health conditions—such as certain heart problems or lung diseases—could prevent someone from joining the trial to ensure safety for all involved.

Gender

ALL

Eligibility criteria

• 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, who have failed first-line standard therapy.
• • 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.