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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Shanghai Chest Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xuwei Cai
birdhome2000@163.com
02122200000
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 28
Treatments
Experimental: Experimental arm
Induction: QL1706 combined with Etoposide and platinum, intravenous infusion (IV), every 3 weeks.~Chemoradiotherapy, followed by QL1706 consolidation, intravenous infusion (IV), every 3 weeks.
Sponsors
Leads: Shanghai Chest Hospital

This content was sourced from clinicaltrials.gov