This study will evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection in combination with Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer.
For voluntary signing of the informed consent form, participants aged 18 to 75 years (inclusive), regardless of gender, are eligible
Histologically or cytologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group [VALG] staging system)
Expected survival ≥ 3 months
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Patients with allergies or intolerance to the EP chemoradiotherapy regimen or any active/auxiliary components of the investigational drug
Active or untreated central nervous system (CNS) metastases identified by computed tomography (CT) or magnetic resonance imaging (MRI) during screening or prior radiographic assessments
Malignant effusions (pleural/ascites/pericardial) refractory to prior interventions (Defined as significant reaccumulation requiring repeat drainage or other interventions within 2 weeks, accompanied by symptomatic worsening)
Active autoimmune diseases , including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), antiphospholipid syndrome, granulomatosis with polyangiitis (Wegener's), Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis (MS)
Single group
Iparomlimab and Tuvonralimab Injection
DrugInduction Therapy: Ipilimumab and tuvonralimab injection, 5 mg/kg, Day 1, every 3 weeks for 4 to 6 cycles. Maintenance therapy: Ipilimumab and tuvonralimab injection, 5 mg/kg, Day 1, every 3 weeks. Maintenance therapy was continued for up to 2 years or until disease progression (PD), intolerable toxicity, withdrawal of informed consent, investigator-determined subject discontinuation from the study, non-compliance with study treatment or procedures, or other reasons specified in the protocol.
Etoposide
DrugInduction Therapy: etoposide, 100 mg/m2, D1-3, every 3 weeks for 4 to 6 cycles.
Cisplatin
DrugInduction Therapy: cisplatin, 25 mg/m², D1-3, every 3 weeks for 4 to 6 cycles.
Targeted Radiation Therapy
RadiationSubjects who achieved a CR, PR, or SD with good local control following induction therapy, were subjected to sequential TRT (≥3Gy×10 or 15, using an involved-field irradiation technique. The specific regimen could be adjusted according to the patient's disease status and the standard practices of the investigator's institutional radiation oncology department)
Progression-Free Survival
PFS was defined as the time from the first administration of the study drug to the first occurrence of objective tumor progression or death from any cause, whichever occurred first.
Objective Response Rate
ORR was defined as the proportion of patients whose best observed response from the first administration of the study drug until the first objective tumor progression was either CR (Complete Response) or PR (Partial Response).
Disease Control Rate
DCR was defined as the proportion of patients whose best observed response from the first administration of the study drug until the first objective tumor progression was CR, PR, or SD (Stable Disease).
Duration of Response
The time from the date of the first tumor assessment documenting CR or PR to the date of the first assessment documenting PD (Progressive Disease) or death from any cause, whichever occurred first, during the study treatment period.
Thoracic Local Control Rate
Defined as the proportion of patients who maintained control of the primary thoracic tumor and regional lymph nodes from the initiation of thoracic radiotherapy (TRT).
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