Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04790409
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2021-02-18
Brief Title:
Sintilimab Combined With Anlotinib in Advanced NSCLC With EGFR Uncommon Mutations
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Department of Medical Oncology Zhejiang Cancer Hospital
Status:
COMPLETED
Status Verified Date:
2023-09
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:
This study was a single-arm open-label phase II study of PD-1 monoclonal antibody combined with anlotinib in the treatment of advanced non-small cell lung cancer NSCLC with EGFR uncommon mutations Twenty-one patients of NSCLC harboring rare EGFR mutations after previous treatments including a platinum-based regimen and a targeted treatment regardless of EGFR Ex20ins were enrolled Patients received sintilimab anti-PD-1 combined with anlotinib multi-target anti-angiogenesis The primary endpoint was the objective response rate ORR based on RECIST 11 Secondary goals included progression-free survival PFS overall survival OS disease control rate DCR based on RECIST 11 safety Sex and tolerance Exploratory objectives include the use of tumor tissue and plasma specimens to detect biomarkers predicting the efficacy of sidilimumab including but not limited to tumor mutation burden TMB PD-L1 expression etc exploring potential predictions in peripheral blood Biomarkers for anti-group efficacy including but not limited to TCR
Detailed Description:
This clinical trial NCT04790409 entitled Sintilimab Combined with Anlotinib in Advanced NSCLC with EGFR Uncommon Mutations has been approved by the Ethics Committee of Zhejiang Cancer Hospital in June 12 2019 IRB-2019-81 Meanwhile we registered our project information on the ClinicalTrialsgov PRS in June 2019 and obtained the status of approved In this study the first patient received treatment on August 26 2019 However due to inexperience and misunderstanding we wrongly missed the next stage of released in PRS Until we realize our mistakes the initial release time can only be on 02182021 Therefore we amend the initial release time here
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