Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04712877
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2020-10-16
Brief Title:
Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers
Sponsor:
Lung Cancer Mutation Consortium
Organization:
Lung Cancer Mutation Consortium
Study Overview
Official Title:
LEADER Neoadjuvant Screening Trial LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers
Status:
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 collaborative screening protocol developed by the Lung Cancer Mutation Consortium LCMC and supported by the Thoracic Surgery Oncology Group TSOG is designed to determine the feasibility of comprehensive molecular profiling to detect actionable oncogenic drivers in patients with suspected early stage lung cancers scheduled to undergo biopsies to establish the diagnosis of lung cancer
The primary purpose of this testing is to determine the presence of 12 oncogenic drivers mutations in EGFR BRAFV600E MET exon 14 KRAS G12C and HER2 rearrangements in ALK RET NTRK EGFR exon 20 insertion and ROS1 and amplification of MET and HER2 that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected
Thoracic Surgery Oncology Group TSOG is a network of surgeons within North American Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer TSOG has aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial TSOGs involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study We estimate we will detect an actionable oncogenic driver in 33 of cases The remaining 66 of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab durvalumab nivolumab and pembrolizumab or other novel agents
The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER screening trial evaluating for efficacy If none of the 10 oncogenic drivers are detected the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy For patients not enrolled on a targeted treatment trial circulating tumor DNA in blood ctDNA will be collected at 3 time points before neoadjuvant treatment after neoadjuvant treatment but before surgery and after surgery This initiative will be correlated with various clinical outcomes Prespecified clinical data will be collected for correlation with these circulating biomarkers
The primary purpose of this testing is to determine the presence of 12 oncogenic drivers mutations in EGFR BRAFV600E MET exon 14 KRAS G12C and HER2 rearrangements in ALK RET NTRK EGFR exon 20 insertion and ROS1 and amplification of MET and HER2 that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected
Thoracic Surgery Oncology Group TSOG is a network of surgeons within North American Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer TSOG has aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial TSOGs involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study We estimate we will detect an actionable oncogenic driver in 33 of cases The remaining 66 of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab durvalumab nivolumab and pembrolizumab or other novel agents
The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER screening trial evaluating for efficacy If none of the 10 oncogenic drivers are detected the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy For patients not enrolled on a targeted treatment trial circulating tumor DNA in blood ctDNA will be collected at 3 time points before neoadjuvant treatment after neoadjuvant treatment but before surgery and after surgery This initiative will be correlated with various clinical outcomes Prespecified clinical data will be collected for correlation with these circulating biomarkers
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?:
None