Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-12
Brief Title:
Liposomal Irinotecan Combination Regimen for First-line Treatment of Small Cell Lung Cancer
Sponsor:
Zhou Chengzhi
Organization:
Guangzhou Institute of Respiratory Disease
Study Overview
Official Title:
Randomized Phase II Clinical Study of Liposomal Irinotecan or Etoposide Combined With Carboplatin and Serplulimab as First-line Treatment for Extensive Stage Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 250000 patients are diagnosed with SCLC every year in the world and nearly 200000 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
Detailed Description:
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 250000 patients are diagnosed with SCLC every year in the world and nearly 200000 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
Trial design This is a multicenter open-label non-comparative randomized Phase II clinical study Sixty patients with extensive stage small cell lung cancer were expected to be enrolled and randomly assigned 11 to either liposomal irinotecan carboplatin serplulimab or etoposide carboplatin serplulimab for treatment The study included a screening period within 28 days a treatment period 4 cycles planned and a follow-up period safety follow-up and PFS follow-up Subjects signed informed consent and underwent baseline examination during the screening period Patients who met the inclusion and exclusion criteria entered the treatment period All subjects completed relevant examinations specified in the protocol during treatment to observe safety tolerability and efficacy The same subject received only one dosing schedule during the study After the treatment period the follow-up period was entered
Treatment regimen Cohort 1 Liposomal irinotecan 50mgm2 ivgtt d1 Carboplatin AUC5 ivgtt d1 Serplulimab 45mgkg 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 mgm2 ivgtt d1-3 Carboplatin AUC5 ivgtt d1 Serplulimab 45mgkg 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
Endpoint Primary endpoint Progression-free survival PFS Secondary endpoints Objective response rate ORR disease control rate DCR overall survival OS and outcome in brain metastases PFS
Safety endpoints Incidence and severity of hematologic and nonhematologic adverse events NCI-CTCAE50
Follow-up After the end of the treatment period the follow-up period was entered which was once every 2 months in the first year and once every 3-4 months in the second to third year
Statistical analysis IBM SPSS software version 250 or above was used for statistical analysis in this study The measurement data were described statistically with mean median standard deviation maximum and minimum values Count data or grade data use case number percentage representation
Trial design This is a multicenter open-label non-comparative randomized Phase II clinical study Sixty patients with extensive stage small cell lung cancer were expected to be enrolled and randomly assigned 11 to either liposomal irinotecan carboplatin serplulimab or etoposide carboplatin serplulimab for treatment The study included a screening period within 28 days a treatment period 4 cycles planned and a follow-up period safety follow-up and PFS follow-up Subjects signed informed consent and underwent baseline examination during the screening period Patients who met the inclusion and exclusion criteria entered the treatment period All subjects completed relevant examinations specified in the protocol during treatment to observe safety tolerability and efficacy The same subject received only one dosing schedule during the study After the treatment period the follow-up period was entered
Treatment regimen Cohort 1 Liposomal irinotecan 50mgm2 ivgtt d1 Carboplatin AUC5 ivgtt d1 Serplulimab 45mgkg 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 mgm2 ivgtt d1-3 Carboplatin AUC5 ivgtt d1 Serplulimab 45mgkg 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
Endpoint Primary endpoint Progression-free survival PFS Secondary endpoints Objective response rate ORR disease control rate DCR overall survival OS and outcome in brain metastases PFS
Safety endpoints Incidence and severity of hematologic and nonhematologic adverse events NCI-CTCAE50
Follow-up After the end of the treatment period the follow-up period was entered which was once every 2 months in the first year and once every 3-4 months in the second to third year
Statistical analysis IBM SPSS software version 250 or above was used for statistical analysis in this study The measurement data were described statistically with mean median standard deviation maximum and minimum values Count data or grade data use case number percentage representation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None