Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649448
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
A Multi-cohort Study of Efbemalenograstim Alfa Injection for Preventing ANC Reduction in Solid Tumor Patients Post Immune-chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-cohort Open-label Multi-center Exploratory Study of Efbemalenograstim Alfa Injection for Preventing Absolute Neutrophil Count ANC Reduction in Solid Tumor Patients Undergoing Immune-chemotherapy Regimen
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EF-001
Brief Summary:
This study is a multi-cohort open-label multi-center exploratory clinical research designed to evaluate the efficacy and safety of Efbemalenograstim alfa Injection in preventing neutropenia reduction in absolute neutrophil count ANC in solid tumor patients undergoing immune checkpoint inhibitor ICI combined chemotherapy A total of 200 solid tumor patients who are scheduled to receive at least 2 cycles of ICI combined chemotherapy will be enrolled The study is divided into three cohorts
Cohort 1 Small cell lung cancer SCLC patients receiving ICI combined with chemotherapy etoposide carboplatincisplatin
Cohort 2 Non-small cell lung cancer NSCLC patients receiving ICI combined with chemotherapy platinum-basedtaxane pemetrexedplatinum
Cohort 3 Esophageal squamous cell carcinoma ESCC patients receiving ICI combined with chemotherapy TP which stands for cisplatin taxane
Cohort 1 Small cell lung cancer SCLC patients receiving ICI combined with chemotherapy etoposide carboplatincisplatin
Cohort 2 Non-small cell lung cancer NSCLC patients receiving ICI combined with chemotherapy platinum-basedtaxane pemetrexedplatinum
Cohort 3 Esophageal squamous cell carcinoma ESCC patients receiving ICI combined with chemotherapy TP which stands for cisplatin taxane
Detailed Description:
This study is a multi-cohort open-label multi-center exploratory clinical trial aimed at evaluating the efficacy and safety of Efbemalenograstim alfa Injection in preventing neutropenia reduction in absolute neutrophil count ANC in solid tumor patients undergoing immune checkpoint inhibitor ICI combined chemotherapy It plans to enroll 200 solid tumor patients who are scheduled to receive at least 2 cycles of ICI combined chemotherapy The study is divided into three cohorts
Cohort 1 Small cell lung cancer SCLC patients receiving ICI combined with chemotherapy etoposide carboplatincisplatin
Cohort 2 Non-small cell lung cancer NSCLC patients receiving ICI combined with chemotherapy platinum-basedtaxane pemetrexedplatinum
Cohort 3 Esophageal squamous cell carcinoma ESCC patients receiving ICI combined with chemotherapy TP which stands for cisplatin taxane
Eligible patients will receive Efbemalenograstim alfa Injection 20 mgdose subcutaneous injection 24-72 hours after the end of each chemotherapy cycle from the 1st to the 4th cycle of ICI combined chemotherapy Investigators must ensure that the first cycle of chemotherapy is administered at the recommended dose according to the protocol For the 2nd to 4th cycles dose delays or adjustments due to toxicity are allowed and investigators may also determine the individual chemotherapy cycles and drug doses based on the patient39s specific condition during these cycles After completing 4 cycles of ICI combined chemotherapy and evaluation patients will receive subsequent treatment according to standard clinical practice
Referencing the 2023 CSCO Guidelines the recommended ICI combined chemotherapy regimens for subjects are as follows
Cohort 1 - SCLC referring to the 342023 CSCO Guidelines for the Diagnosis and Treatment of SCLC34
Immune drugs choose one
Atezolizumab 1200 mg d1 Q3W Durvalumab 1500 mg d1 Q3W Serplulimab 45 mgkg d1 Q3W Adebelimab 20 mgkg d1 Q3W
Chemotherapy regimens choose one
EC Q3W Carboplatin AUC5-6 d1 Etoposide 80-100 mgm2 d1-3 EP Q3W Cisplatin 75-80 mgm2 d1 Etoposide 80-100 mgm2 d1-3
Cohort 2 - NSCLC referring to the 342023 CSCO Guidelines for the Diagnosis and Treatment of NSCLC34
NSCLC Squamous Cell Carcinoma - Immune drugs choose one
Pembrolizumab 200 mg d1 Q3W Camrelizumab 200 mg d1 Q3W Sintilimab 200 mg d1 Q3W Tislelizumab 200 mg d1 Q3W Serplulimab 45 mgkg d1 Q3W Atezolizumab 1200 mg d1 Bevacizumab 15 mgkg d1 Q3W Sugemalimab 1200 mg d1 Q3W Anplitumab 200 mg d1 Q3W
NSCLC Squamous Cell Carcinoma - Chemotherapy regimens choose one
Carboplatin AUC5-6 d1 Taxane Paclitaxel 175-200 mgm2 d1 or Albumin-bound Paclitaxel 200-260 mgm2 d1 Q3W CisplatinCarboplatin 75 mgm2AUC5-6 d1 Gemcitabine 1000 mgm2 d1 d8 Q3W
NSCLC Non-Squamous Cell Carcinoma - Immune drugs choose one
Pembrolizumab 200 mg d1 Q3W Camrelizumab 200 mg d1 Q3W Sintilimab 200 mg d1 Q3W Tislelizumab 200 mg d1 Q3W Atezolizumab 1200 mg d1 Sugemalimab 1200 mg d1 Q3W
NSCLC Non-Squamous Cell Carcinoma - Chemotherapy regimens choose one
Cisplatin 75 mgm2 d1 Pemetrexed 500 mgm2 d1 Q3W Carboplatin AUC5-6 d1 Pemetrexed 500 mgm2 d1 Q3W
Cohort 3 - ESCC referring to the 342023 CSCO Guidelines for the Diagnosis and Treatment of Esophageal Cancer34
Immune drugs choose one
Camrelizumab 200 mg d1 Q3W Toripalimab 240 mg d1 Q3W Sintilimab 200 mg d1 Q3W Tislelizumab 200 mg d1 Q3W Serplulimab 3 mgkg intravenous infusion d1 Q2W
Chemotherapy regimen
TP regimen Cisplatin 60-80 mgm2 intravenous infusion d1 Taxane Paclitaxel 175 mgm2 d1 or Albumin-bound Paclitaxel 200-260 mgm2 d1 Q3W Note The chemotherapy schedule for cisplatin and etoposide can be modified as needed while maintaining the total dose administered
Cohort 1 Small cell lung cancer SCLC patients receiving ICI combined with chemotherapy etoposide carboplatincisplatin
Cohort 2 Non-small cell lung cancer NSCLC patients receiving ICI combined with chemotherapy platinum-basedtaxane pemetrexedplatinum
Cohort 3 Esophageal squamous cell carcinoma ESCC patients receiving ICI combined with chemotherapy TP which stands for cisplatin taxane
Eligible patients will receive Efbemalenograstim alfa Injection 20 mgdose subcutaneous injection 24-72 hours after the end of each chemotherapy cycle from the 1st to the 4th cycle of ICI combined chemotherapy Investigators must ensure that the first cycle of chemotherapy is administered at the recommended dose according to the protocol For the 2nd to 4th cycles dose delays or adjustments due to toxicity are allowed and investigators may also determine the individual chemotherapy cycles and drug doses based on the patient39s specific condition during these cycles After completing 4 cycles of ICI combined chemotherapy and evaluation patients will receive subsequent treatment according to standard clinical practice
Referencing the 2023 CSCO Guidelines the recommended ICI combined chemotherapy regimens for subjects are as follows
Cohort 1 - SCLC referring to the 342023 CSCO Guidelines for the Diagnosis and Treatment of SCLC34
Immune drugs choose one
Atezolizumab 1200 mg d1 Q3W Durvalumab 1500 mg d1 Q3W Serplulimab 45 mgkg d1 Q3W Adebelimab 20 mgkg d1 Q3W
Chemotherapy regimens choose one
EC Q3W Carboplatin AUC5-6 d1 Etoposide 80-100 mgm2 d1-3 EP Q3W Cisplatin 75-80 mgm2 d1 Etoposide 80-100 mgm2 d1-3
Cohort 2 - NSCLC referring to the 342023 CSCO Guidelines for the Diagnosis and Treatment of NSCLC34
NSCLC Squamous Cell Carcinoma - Immune drugs choose one
Pembrolizumab 200 mg d1 Q3W Camrelizumab 200 mg d1 Q3W Sintilimab 200 mg d1 Q3W Tislelizumab 200 mg d1 Q3W Serplulimab 45 mgkg d1 Q3W Atezolizumab 1200 mg d1 Bevacizumab 15 mgkg d1 Q3W Sugemalimab 1200 mg d1 Q3W Anplitumab 200 mg d1 Q3W
NSCLC Squamous Cell Carcinoma - Chemotherapy regimens choose one
Carboplatin AUC5-6 d1 Taxane Paclitaxel 175-200 mgm2 d1 or Albumin-bound Paclitaxel 200-260 mgm2 d1 Q3W CisplatinCarboplatin 75 mgm2AUC5-6 d1 Gemcitabine 1000 mgm2 d1 d8 Q3W
NSCLC Non-Squamous Cell Carcinoma - Immune drugs choose one
Pembrolizumab 200 mg d1 Q3W Camrelizumab 200 mg d1 Q3W Sintilimab 200 mg d1 Q3W Tislelizumab 200 mg d1 Q3W Atezolizumab 1200 mg d1 Sugemalimab 1200 mg d1 Q3W
NSCLC Non-Squamous Cell Carcinoma - Chemotherapy regimens choose one
Cisplatin 75 mgm2 d1 Pemetrexed 500 mgm2 d1 Q3W Carboplatin AUC5-6 d1 Pemetrexed 500 mgm2 d1 Q3W
Cohort 3 - ESCC referring to the 342023 CSCO Guidelines for the Diagnosis and Treatment of Esophageal Cancer34
Immune drugs choose one
Camrelizumab 200 mg d1 Q3W Toripalimab 240 mg d1 Q3W Sintilimab 200 mg d1 Q3W Tislelizumab 200 mg d1 Q3W Serplulimab 3 mgkg intravenous infusion d1 Q2W
Chemotherapy regimen
TP regimen Cisplatin 60-80 mgm2 intravenous infusion d1 Taxane Paclitaxel 175 mgm2 d1 or Albumin-bound Paclitaxel 200-260 mgm2 d1 Q3W Note The chemotherapy schedule for cisplatin and etoposide can be modified as needed while maintaining the total dose administered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None