A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy:A Phase II Trial
The study is being conducted to evaluation of the Efficacy and Safety of QL1706 Combined with Chemotherapy Induction in Sequential Immunotherapy Consolidation After Concurrent Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer(LS-SCLC), and Exploration of the Correlation Between Biomarkers (PD-L1, TMB, ctDNA, etc.) Related to QL1706 Treatment and Treatment Efficacy and Prognosis. QL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.
• The patient must be aged between 18 and 75 years (inclusive of boundary values), and both males and females are eligible.
• Pathologically confirmed LS-SCLC
• Investigator confirmation of at least one measurable lesion, as defined by RECIST v1.1
• ECOG performance status of 0 or 1
• Forced expiratory volume in one second (FEV₁) \> 1.0 L
• No clinically significant interstitial lung disease on baseline CT or PET/CT.
• Adequate organ and bone-marrow function (all tests performed within 7 days prior to first dose; no transfusions, growth factors, albumin, or other corrective therapies within 14 days):Hemoglobin ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 90 × 10⁹/L,Serum creatinine ≤ 1.5 × ULN, TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Albumin (ALB) ≥ 25 g/L,INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN (subjects on prophylactic anticoagulation must have values within a safe therapeutic range, per investigator)
• Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use reliable contraception from screening until 3 months after the last dose; male subjects must agree to use effective contraception or have undergone surgical sterilization for the same period.
• No prior systemic anti-tumor therapy before enrollment.
⁃ Estimated life expectancy ≥ 12 weeks.