Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
A Prospective Cohort Study of Neoadjuvant Chemotherapy Plus Sintillumab in the Treatment of Resectable NSCLC
Sponsor:
Tang-Du Hospital
Organization:
Tang-Du Hospital
Study Overview
Official Title:
A Prospective Cohort Study of Neoadjuvant Chemotherapy Plus Sintillumab in the Treatment of Resectable NSCLC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 uses a prospective cohort designSubjects are randomly divided into three groups A B C before surgery Group A gets 3 cycles of sintilimab chemo Group B gets 2 cycles 1 cycle and Group C gets 1 cycle 2 cycles
Non-squamous NSCLC subjects receive pemetrexedalbumin paclitaxel platinum while squamous NSCLC subjects get albumin paclitaxel platinum
Non-squamous NSCLC subjects receive pemetrexedalbumin paclitaxel platinum while squamous NSCLC subjects get albumin paclitaxel platinum
Detailed Description:
This study adopts a prospective cohort study designThe subjects will be randomly divided into three groups according to the ratio of 111 prior to surgery group A group B and group C The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy group B will receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab and group C will receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab Non-squamous NSCLC subjects will receive pemetrexedalbumin paclitaxel and platinum cisplatincarboplatin and squamous NSCLC subjects will receive albumin paclitaxel and platinum cisplatin carboplatin
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?:
False
Is an FDA AA801 Violation?:
None