Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336954
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-19
Brief Title:
Adibelimab Famitinib and Chemotherapy for Advanced NSCLC After PD-1 Inhibitor Failure
Sponsor:
Second Affiliated Hospital of Xian Jiaotong University
Organization:
Second Affiliated Hospital of Xian Jiaotong University
Study Overview
Official Title:
Exploratory Study of Adibelimab Combined With Famitinib and Chemotherapy for the Treatment of Patients With Driver Gene-Negative Locally Advanced or Metastatic NSCLC Progressing After PD-1 Monoclonal Antibody Combined With Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 prospective single-arm trial explores the efficacy of Adibelimab monoclonal antibody combined with Famitinib and chemotherapy in treating locally advanced or metastatic NSCLC patients with negative driver genes who have progressed after PD-1 monoclonal antibody and chemotherapy treatment The study focuses on assessing progression-free survival PFS in 40 participants Key objectives include evaluating PFS and understanding the progression patterns post-first-line immunotherapy with an interest in whether switching from PD-1 to PD-L1 inhibitors can overcome immune resistance
Detailed Description:
This study is a prospective single-arm clinical investigation It aims to assess the effectiveness of the Adibelimab monoclonal antibody in combination with Famitinib and chemotherapy for treating patients with locally advanced or metastatic non-small cell lung cancer NSCLC without driver mutations who have progressed following initial treatment with PD-1 monoclonal antibodies and chemotherapy The studys primary focus is on evaluating progression-free survival PFS among the 40 participants spanning from December 2023 to December 2026 It intends to explore the therapeutic potential of switching from PD-1 to PD-L1 inhibitors in overcoming immune resistance and identify subgroups that may particularly benefit from this treatment strategy thereby providing insights into personalized therapy for advanced NSCLC
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