Lung cancer is a malignant tumor with high incidence and mortality in China and the world, among which small cell lung cancer (SCLC) accounts for 13% to 17% of lung cancer, and about 250,000 patients are diagnosed with SCLC every year in the world, and nearly 200,000 people die from it. Due to the high degree of malignancy of SCLC, it is easy to develop distant metastasis in the early stage, and most of the patients are diagnosed in the late stage with poor prognosis. Although SCLC is sensitive to chemotherapy and radiotherapy and has a high remission rate after initial treatment, it is prone to secondary drug resistance and relapse. SCLC is a low-differentiated, high-grade neuroendocrine tumor that can be classified into limited-stage and extensive stage (ES-SCLC). Etoposide combined with cisplatin (EP regimen) or carboplatin (EC regimen), irinotecan combined with cisplatin (IP regimen) or carboplatin (IC regimen) are the basis of standard first-line therapy for ES-SCLC. Immunocombined chemotherapy has also become the first-line standard treatment for ES-SCLC, among which serplulimab + etoposide + carboplatin is recommended by CSCO guidelines for first-line treatment. Liposomal irinotecan is irinotecan encapsulated by liposomes, which has advantages in safety. The study is expected to achieve good efficacy, improve the quality of life and prolong the survival of patients by combining the immune drug serplulimab on the basis of IC regimen. After replacing ordinary irinotecan with liposomal irinotecan, this study aims to compare the efficacy and safety of liposomal irinotecan + carboplatin + serplulimab with the first-line standard regimen (etoposide + carboplatin + serplulimab) in patients with extensive stage small-cell lung cancer, providing a better basis for clinical use.
Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF)；
Age ≥18 years；
Patients with pathologically or histologically confirmed extensive stage small cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG staging system)；
The patient had not previously received any form of antitumor therapy；
Patients with large cell neuroendocrine tumor and mixed small cell carcinoma；
Patients with active brain metastases or central nervous system invasion； confirmed by imaging evaluation and/or biopsy (prednisone equivalent dose ≥10mg)；
Allergic reaction to any investigational drug or its ingredients；
The patient has previously received other antibodies/drugs that target immune checkpoints, such as PD-1, PD-L1, CTLA4, etc；
Parallel
Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab Injection
DrugCohort 1: Liposomal irinotecan: 50mg/m2, ivgtt, d1; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable. Cohort 2: Etoposide: 100 mg/m2, ivgtt, d1-3; Carboplatin AUC=5, ivgtt, d1; Serplulimab: 4.5mg/kg, ivgtt, d1; The drug was administered once every three weeks for a total of 4 cycles. After 4 cycles, serplulimab is maintained until disease progression or toxicity becomes intolerable.
Progression-free survival（PFS）
The PFS will be analyzed using Kaplan-Meier method and 95% bilateral confidence intervals will be calculated
Objective response rate（ORR）
ORR use cases, percentage representation
Disease control rate（DCR）
DCR use cases, percentage representation
Overall survival（OS）
The OS will be analyzed using Kaplan-Meier method and 95% bilateral confidence intervals will be calculated
Incidence and severity of hematological and non-hematological adverse events
Safety: The number and frequency of adverse events, serious adverse events, and treatment-related adverse events (NCI CTCAE v5.0) individually and collectively were listed and the incidence rate was calculated.
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Zhou Chengzhi
Lead sponsor
Guangzhou Institute of Respiratory Disease
Sponsor institution
Sun Yat-sen University
Collaborator
Hunan Cancer Hospital
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
First People's Hospital of Foshan
Collaborator
Youjiang Medical College for Nationalities
Collaborator
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