NCT07019675

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-29
• Primary completion: 2027-02-20
• Completion: 2027-10-20
• First posted: 2025-06-13
• Last updated: 2025-12-08

Locations

17 sites across 1 country: China