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Recruiting NCT07019675

A Study of SKB518 in Patients With Lung Cancer

Phase II Interventional Lung Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SKB518, Tislelizumab, Carboplatin.
Who it may be relevant to
Registry conditions: Lung Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug SKB518
    SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
  • Drug Tislelizumab
    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.
  • Drug Carboplatin
    Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles

Primary outcome measures

  • AE [Time frame: Up to 24 months]
  • ORR in specific arms [Time frame: Up to 24 months]
  • PFS in specific arm [Time frame: Up to 24 months]
Secondary outcome measures (5)
  • PFS in specific arms [Time frame: Up to 24 months]
  • DOR in specific arms [Time frame: Up to 24 months]
  • OS [Time frame: Up to 24 months]
  • Pharmacokinetics [Time frame: Up to 24 months]
  • Immunogenicity [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 17 centers
  • Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen
  • Cancer Hospital of Guangxi Medical University — Nanning
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • Hubei Cancer Hospital — Wuhan
  • Renmin Hospital of Wuhan University — Wuhan
  • Xiangyang Central Hospital — Xiangyang
  • Hunan Cancer Hospital — Changsha
  • Jiangxi Cancer Hospital — Nanchang
  • … and 9 more centers

Identifiers

NCT: NCT07019675 · SKB518-II-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗