Liposomal Irinotecan Combination Regimen for First-line Treatment of Small Cell Lung Cancer

Sponsor
Zhou Chengzhi
Study ID
NCT06462105
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Hydrochloride Liposome Injection；Carboplatin Injection；Serplulimab Injection — DRUG
    Cohort 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.

Study Details

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.

Key Dates

Start date
Jul 5, 2024
Status verified
Jun 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal irinotecan + Carboplatin + Serplulimab
    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.
  • Experimental: Etoposide + Carboplatin + Serplulimab
    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.

Primary Outcome Measure

Progression-free survival（PFS） [ Time Frame: 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. ]

Central Contacts

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