Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-02 @ 5:25 AM
Study NCT ID:
NCT07039656
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy
Sponsor:
Wen-zhao ZHONG
Organization:
Study Overview
Official Title:
Toripalimab Combined With Chemotherapy as Postoperative Adjuvant Therapy for Non-Small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy: A Two-Cohort, Multicenter Phase II Trial
Status:
RECRUITING
Status Verified Date:
2025-06
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 two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment status, as measured by disease-free survival (DFS) and overall survival (OS).
Researchers will compare outcomes between two cohorts:
1. Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy;
2. Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.
Researchers will compare outcomes between two cohorts:
1. Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy;
2. Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.
Detailed Description:
None
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?: