Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:58 PM
Study NCT ID:
NCT07408635
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer
Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Organization:
Study Overview
Official Title:
IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy to Convert Initially Unresectable Stage III Non-Small Cell Lung Cancer To Resectable Disease: a Phase II, Single-Arm Clinical Trial
Status:
RECRUITING
Status Verified Date:
2026-02
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 is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.
Detailed Description:
NSCLC patients receive IBI363 combined with platinum-based chemotherapy. If multidisciplinary team (MDT) assessment determines the patient is surgically eligible, surgery is performed followed by 1 year of standard adjuvant therapy. If, after 4 treatment cycles, MDT assessment determines the tumor remains unresectable, concurrent chemoradiotherapy followed by immune checkpoint inhibitor consolidation therapy is administered. This study aims to evaluate the efficacy of IBI363 combined with chemotherapy for neoadjuvant treatment of initially unresectable NSCLC based on R0 resection rate, major pathological response (MPR) rate, and pathological complete response (pCR) rate.
Study Oversight
Has Oversight DMC:
False
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?: