NCT06789796

a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy.

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.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 636 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab (QL1706)	5mg/kg , every 3 weeks
DRUG	placebo for QL1604	every 3 weeks
DRUG	QL1604	200mg, every 3 weeks
DRUG	placebo for Iparomlimab and Tuvonralimab (QL1706)	every 3 weeks

Timeline

• Start date: 2025-02-01
• Primary completion: 2028-03-01
• Completion: 2030-03-01
• First posted: 2025-01-23
• Last updated: 2025-02-11