Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480864
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-20
Brief Title:
Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Small Cell Lung Cancer
Sponsor:
Yunpeng Liu
Organization:
China Medical University China
Study Overview
Official Title:
Adebrelimab Plus Apatinib for Maintenance Treatment of Extensive Small Cell Lung Cancer After First-line Induction With Adebrelimab Plus Chemotherapy a Prospective Single-arm Phase II Clinical Trial
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:
To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy
Detailed Description:
This is a prospective single-arm trial To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy
Induction Period Participants received adebrelimab 1200 mg iv Day1 carboplatin AUC 4-5 mgmLmincisplatin 75 mgm2 etoposide 100 mgm2 D1-3 for 4-6 cycles of three weeks
Maintenance phase Participants received adebrelimab 1200mg iv Day1 apatinib 250mg po daily once every three weeks
Follow-up If the participants have progression disease PD after maintenance therapy based on the investigators judgement that the participants may still benefit from continued treatment with adebrelimab in combination with apatinib they may continue to receive maintenance therapy with or without other therapy until the PD or intolerable
The primary endpoint is progression-free survival PFS Secondary endpoints include objective remission rate ORR disease control rate DCR duration of remission DoR and overall survival OS PFS2 defined as time from enrolment to second disease progression or death Our study will also explore biomarkers including haematopoietic factors IL-6IL-8 IL-10 etc PD-L1 expression T-cell subsets T-cell immunoprecision typing and regulatory T-cell counts The data from our study will provide the basis for further prospective clinical trials Phase III
Induction Period Participants received adebrelimab 1200 mg iv Day1 carboplatin AUC 4-5 mgmLmincisplatin 75 mgm2 etoposide 100 mgm2 D1-3 for 4-6 cycles of three weeks
Maintenance phase Participants received adebrelimab 1200mg iv Day1 apatinib 250mg po daily once every three weeks
Follow-up If the participants have progression disease PD after maintenance therapy based on the investigators judgement that the participants may still benefit from continued treatment with adebrelimab in combination with apatinib they may continue to receive maintenance therapy with or without other therapy until the PD or intolerable
The primary endpoint is progression-free survival PFS Secondary endpoints include objective remission rate ORR disease control rate DCR duration of remission DoR and overall survival OS PFS2 defined as time from enrolment to second disease progression or death Our study will also explore biomarkers including haematopoietic factors IL-6IL-8 IL-10 etc PD-L1 expression T-cell subsets T-cell immunoprecision typing and regulatory T-cell counts The data from our study will provide the basis for further prospective clinical trials Phase III
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