Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06123754
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-10-25
Brief Title:
Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC
Sponsor:
3D Medicines Sichuan Co Ltd
Organization:
3D Medicines
Study Overview
Official Title:
A Randomized Controlled Double-blind Multicenter Phase III Clinical Study of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy in Patients With Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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 is a randomized controlled double-blind multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvantadjuvant therapy in subjects with resectable stage IIIA and IIIB N2 NSCLC Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC
Detailed Description:
A total of approximately 390 participants are planned to be enrolled in this study After being screened and qualified the subjects will be randomly assigned to receive Envalfolimab or placebo plus platinum-based doublet chemotherapy in 11 ratio for a total of 3-4 cycles of neoadjuvant therapy determined by the investigator the feasibility of surgery is evaluated by the investigator within 4-6 weeks after the end of neoadjuvant therapy and surgery will be performed Envafolimab experimental group or placebo control group will be administered after surgery After completion of treatment subjects will enter a follow-up phase including safety follow-up tumor disease follow-up and survival follow-upAll randomized subjects in this study are required to receive tumor imaging evaluation as scheduled and get continuous safety assessment during the srceening and treatment period
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