Liposomal Irinotecan Combination Regimen for First-line Treatment of Small Cell Lung Cancer
NCT Number: NCT06462105
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Small Cell Lung Cancer
Interventions: DRUG: Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab Injection
Sponsor: Zhou Chengzhi
Collaborators: Sun Yat-sen University|Hunan Cancer Hospital|Guangdong Provincial Hospital of Traditional Chinese Medicine|First People's Hospital of Foshan|Affiliated Hospital of Youjiang Medical University for Nationalities
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2027-06-30

Summary:
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.

Primary Outcome Measures: Progression-free survival（PFS）, The PFS will be analyzed using Kaplan-Meier method and 95% bilateral confidence intervals will be calculated, The time between the subject's signing of the informed consent and the onset of tumor progression (according to RECIST v1.1 criteria) or death.
Secondary Outcome Measures: Objective response rate（ORR）, ORR use cases, percentage representation, Percentage of tumor volume reduction to complete response (CR) and partial response (PR) (according to RECIST v1.1 criteria).|Disease control rate（DCR）, DCR use cases, percentage representation, Best tumor response based on RECIST1.1 criteria, the proportion of CR, PR and SD.|Overall survival（OS）, The OS will be analyzed using Kaplan-Meier method and 95% bilateral confidence intervals will be calculated, The time between the subject signing the informed consent form and the patient's death due to various causes.|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., The time between the subject signing the informed consent and the end of treatment