Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421298
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-10
Brief Title:
A Prospective Single-arm Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy
Sponsor:
Jinghui Wang
Organization:
Beijing Chest Hospital Capital Medical University
Study Overview
Official Title:
A Prospective Single-arm Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The second-line treatment for patients who have progressed after first-line immune checkpoint inhibitor therapy is chemotherapy based on docetaxel and other drugs The treatment effect is limited The median survival time of them are 6 months So there is a huge unmet medical need
This study is a Prospective Single-arm Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy 30 patients will be enrolled
The main endpoint is PFSand the secondary endpoint are OSDCRDORORR and so on
This study is a Prospective Single-arm Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy 30 patients will be enrolled
The main endpoint is PFSand the secondary endpoint are OSDCRDORORR and so on
Detailed Description:
This is a Prospective Single-arm Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy
30 patients will be enrolled These patients will be treated with chemotherapy combined with sintilimab and Tafolecimab
The main endpoint is PFSand the secondary endpoint are OSDCRDORORR and so on
30 patients will be enrolled These patients will be treated with chemotherapy combined with sintilimab and Tafolecimab
The main endpoint is PFSand the secondary endpoint are OSDCRDORORR and so on
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