Phase II Study of QL1706 With Chemotherapy Induction Followed by Immunotherapy Consolidation After Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the efficacy and safety of QL1706 combined with chemotherapy induction followed by sequential immunotherapy consolidation after concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer LS-SCLC. This phase II trial also explores the relationship between biomarkers such as PD-L1, TMB, and ctDNA with treatment efficacy and prognosis. QL1706 is a bispecific antibody product targeting PD-1 and CTLA-4, designed to enhance immune response against cancer cells. Participants receive induction therapy with QL1706 combined with etoposide and platinum chemotherapy given intravenously every three weeks for two cycles. This is followed by concurrent thoracic radiotherapy with chemotherapy. Patients achieving or approaching complete response then receive consolidation treatment with QL1706 via intravenous infusion every three weeks. The radiotherapy dosing may vary, including once or twice daily fractions, and prophylactic cranial irradiation is given to eligible participants. During the study, participants are monitored for disease progression and survival outcomes up to 12 months after the last patient entry, with some measures followed up to 24 months. Assessments include tumor response evaluations, quality of life questionnaires, and monitoring of adverse events. Biomarker correlations with treatment outcomes are also studied over up to two years. The total study duration extends through the treatment and follow-up phases, concluding by August 2028.

A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy