SKB518 treatment for people with lung cancer

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer

This trial will test whether SKB518 given alone is safe and can shrink tumors in adults with non-small cell or small cell lung cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (industry)
• Locations: 17 sites (Shenzhen, Guangdong and 16 other locations)
• Trial ID: NCT07019675 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 years with confirmed NSCLC or SCLC, at least one measurable lesion, ECOG 0–1, expected survival ≥12 weeks, and adequate organ function are the ideal candidates.

Not a fit: People with uncontrolled symptomatic cardiovascular disease, prior steroid‑treated pneumonitis or active interstitial lung disease, those on recent systemic corticosteroids or other immunosuppressants, or known HIV infection are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, SKB518 could offer a new treatment option that controls tumor growth with an acceptable safety profile for some people with lung cancer.

How similar studies have performed: Related approaches such as PD‑1/PD‑L1 inhibitors combined with chemotherapy have shown benefit in lung cancer, but SKB518 itself is investigational with limited published data.

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.
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 this trial is running

Shenzhen, Guangdong and 16 other locations

• 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)
• Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (RECRUITING)
• Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (RECRUITING)
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China (RECRUITING)
• Affiliated Cancer Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (RECRUITING)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (RECRUITING)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (RECRUITING)
• Cancer Hospital Chinese Academy of Medical Science — Beijing, China (RECRUITING)
• Shanghai Pulmonary Hospital (Affiliated to Tongji University) — Shanghai, China (RECRUITING)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Xin Li

Conditions: Lung Carcinoma