Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614231
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIAN2 Non-small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Phase II Trial of Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIAN2 Non-small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2III non-small cell lung cancer
Detailed Description:
This study is a prospective single-arm single-center phase II clinical trial to investigate the efficacy and safety of neoadjuvant treatment with tirilizumab in combination with chemotherapy in patients with initially inoperable stage IIIN2 non-small cell lung cancer
Patients with stage IIIN2 non-small cell lung cancer that is initially inoperable and clearly staged and meets the enrollment criteria will receive 3 cycles of tirilizumab 200 mg in combination with chemotherapy and will be evaluated by imaging of their tumor status After MDT evaluation patients will either undergo surgery or be withdrawn from the study and receive a combination of radiotherapy and chemotherapy with postoperative adjuvant therapy at the discretion of the physician The primary endpoint of this study is the surgical conversion rate secondary endpoints include MPR pCR safety and EFS
Patients with stage IIIN2 non-small cell lung cancer that is initially inoperable and clearly staged and meets the enrollment criteria will receive 3 cycles of tirilizumab 200 mg in combination with chemotherapy and will be evaluated by imaging of their tumor status After MDT evaluation patients will either undergo surgery or be withdrawn from the study and receive a combination of radiotherapy and chemotherapy with postoperative adjuvant therapy at the discretion of the physician The primary endpoint of this study is the surgical conversion rate secondary endpoints include MPR pCR safety and EFS
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