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
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Cancer Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Jiangxi Cancer Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Cancer Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Shanghai Pulmonary Hospital Affiliated to Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Shanxi Cancer hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Affiliated Cancer Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.