Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426511
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Brief Title:
ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Consolidation Toripalimab Therapy Guided by Circulating Tumor DNA ctDNA-Minimal Residual Disease MRD for Completely Resected Stage IB-IIIA Non-small-cell Lung Cancer Without EGFR or ALK Alterations for Nonsquamous 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:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTINUE
Brief Summary:
This study aims to incorporate circulating tumor DNA ctDNA-minimal residual disease MRD to personalize the administration of consolidation toripalimab therapy in resected stage IB-IIIA non-small-cell lung cancer NSCLC after adjuvant therapy Toripalimab is a humanized monoclonal antibody for human programmed cell death protein 1 Toripalimab was approved as a consolidation treatment after perioperative therapy in combination with chemotherapy for resectable stage III NSCLC
Detailed Description:
Most patients with stage IB-IIIA non-small cell lung cancer NSCLC are managed with surgery follow by standard-of-care adjuvant platinum-based chemotherapy However postoperative recurrence rates remain high Recent years the role of checkpoint inhibitors has been proven to be effective in patients with advanced NSCLC and even in patients with resectable NSCLC Emerging data supports the use of consolidation checkpoint inhibitors therapy in localized NSCLC Based on the results from Neotorch trial consolidation toripalimab therapy led to a significant improvement in event-free survival for patients with resectable NSCLC However not all patients may benefit from consolidation therapy Circulating tumor DNA ctDNA has emerged as a promising biomarker for early detection of minimal residual disease MRD in cancer surveillance There is a critical need to identify MRD after curative therapies to determine which patients may benefit from consolidation toripalimab therapy The aim of this study is to explore whether observation follow-up for patients with negative ctDNA after adjuvant therapy has a non-inferior prognosis for patients with positive ctDNA and received consolidation toripalimab therapy This study aims to incorporate ctDNA-MRD to personalize the administration of consolidation toripalimab therapy for completely resected stage IB-IIIA NSCLC without EGFR or ALK alterations for nonsquamous NSCLC
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