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A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer.
Official title: A Phase III, Randomized, Controlled, Open-label Clinical Study to Compare the Efficacy and Safety of QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy as First-line Treatment in Participants With Extensive-stage Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
556
Start Date
2026-10-15
Completion Date
2030-06-15
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
QLC5508
QLC5508 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.
QL2107
QL2107 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for QL2107 will be 2 years.
Tislelizumab
Tislelizumab will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for Tislelizumab will be 2 years.
Carboplatin
Carboplatin will be administered intravenously once every 3 weeks. Carboplatin treatment will be administered for up to 4 cycles.
Cisplatin
Cisplatin will be administered intravenously once every 3 weeks. Cisplatin treatment will be administered for up to 4 cycles.
Etoposide
Etoposide will be administered intravenously once every 3 weeks. Etoposide treatment will be administered for up to 4 cycles.