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.
This is a prospective, single-arm, multicenter clinical study assessing 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. As well as, this study aimed to longitudinally monitor the dynamic changes of molecular residual disease in patients with extensive-stage small cell lung cancer to evaluate treatment efficacy and explore the potential application value of MRD as a biomarker for efficacy assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Induction 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.
Induction Therapy: etoposide, 100 mg/m2, D1-3, every 3 weeks for 4 to 6 cycles.
Induction Therapy: cisplatin, 25 mg/m², D1-3, every 3 weeks for 4 to 6 cycles.
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.
Time frame: 1 year
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).
Time frame: 1 year
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).
Time frame: 1 year
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.
Time frame: 1 year
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).
Time frame: 1 year
Overall Survival
The time from the first administration of the study drug to death from any cause.
Time frame: 1 year
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Subjects 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)