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a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy.
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
The study is being conducted to evaluate the efficacy and safety of QL1706 versus QL1604 monotherapy as consolidation treatment in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after concurrent or sequential chemoradiotherapy. QL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.
Official title: A Randomized, Double-blind Phase III Clinical Study of QL1706 Versus QL1604 as Consolidation Treatment in Patients With Limited-stage Small Cell Lung Cancer Who Have Not Experienced Disease Progression After Concurrent or Sequential Chemoradiotherapy.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
636
Start Date
2025-02
Completion Date
2030-03
Last Updated
2025-02-11
Healthy Volunteers
No
Conditions
Interventions
Iparomlimab and Tuvonralimab (QL1706)
5mg/kg , every 3 weeks
placebo for QL1604
every 3 weeks
QL1604
200mg, every 3 weeks
placebo for Iparomlimab and Tuvonralimab (QL1706)
every 3 weeks