A Phase 2 interventional study of SKB518 and Tislelizumab in Lung Carcinoma, sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. Recruiting at 17 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 192 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is the lead sponsor of 55 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SKB518 monotherapy
Drug: SKB518
SKB518+Tislelizumab or Tislelizumab monotherapy
Drug: SKB518 · Drug: Tislelizumab
SKB518+Tislelizumab+Carboplatin
Drug: SKB518 · Drug: Tislelizumab · Drug: Carboplatin
SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
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.
Also known as: Tevimbra
Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles
AE
Incidence and severity of Adverse Events (AEs)
Time frame: Up to 24 months
ORR in specific arms
Objective Response Rate (ORR) assessed by the investigators per RECIST v1.1
Time frame: Up to 24 months
PFS in specific arm
Progression-Free Survival (PFS) assessed by the investigators per RECIST v1.1
Time frame: Up to 24 months
PFS in specific arms
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Time frame: Up to 24 months
DOR in specific arms
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Time frame: Up to 24 months
OS
Time from start of treatment to death due to any reason.
Time frame: Up to 24 months
Pharmacokinetics
Maximum and minimum drug concentrations (Cmax and Cmin) of SKB518-ADC and SKB518-TAb (antibody-drug conjugate and total antibody forms of SKB518) in Serum; Cmax and Cmin of SKB518-Free Payload in Plasma
Time frame: Up to 24 months
Immunogenicity
Anti-Drug Antibody(ADA) Titre of SKB518
Time frame: Up to 24 months
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.