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
1 other identifier
interventional
192
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2025
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2025
CompletedFirst Posted
Study publicly available on registry
June 13, 2025
CompletedStudy Start
First participant enrolled
August 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 20, 2027
May 8, 2026
May 1, 2026
1.5 years
June 5, 2025
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
AE
Incidence and severity of Adverse Events (AEs)
Up to 24 months
ORR in specific arms
Objective Response Rate (ORR) assessed by the investigators per RECIST v1.1
Up to 24 months
PFS in specific arm
Progression-Free Survival (PFS) assessed by the investigators per RECIST v1.1
Up to 24 months
Secondary Outcomes (5)
PFS in specific arms
Up to 24 months
DOR in specific arms
Up to 24 months
OS
Up to 24 months
Pharmacokinetics
Up to 24 months
Immunogenicity
Up to 24 months
Study Arms (3)
2L+ SCLC or non-Squamous NSCLC
EXPERIMENTALSKB518 monotherapy
2L SCLC
EXPERIMENTALSKB518+Tislelizumab or Tislelizumab monotherapy
1L ES-SCLC
EXPERIMENTALSKB518+Tislelizumab+Carboplatin
Interventions
Tislelizumab is administered every 3 weeks(200 mg, Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles
SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Symptomatic or uncontrolled cardiovascular disease
- History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
- 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.
- Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, China
Shanghai Pulmonary Hospital (Affiliated to Tongji University)
Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2025
First Posted
June 13, 2025
Study Start
August 29, 2025
Primary Completion (Estimated)
February 20, 2027
Study Completion (Estimated)
October 20, 2027
Last Updated
May 8, 2026
Record last verified: 2026-05