Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06538038
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Prospective Non-Interventional Study Comparing Osimertinib - Chemotherapy for EGFR-Mutated NSCLC Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Non-Interventional Study Comparing Standard of Care Osimertinib - Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer NSCLC Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the study is to collect data on patients treated outside of a clinical trial in routine clinical practice with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor EGFR-mutant Non-Small Cell Lung Cancer NSCLC to better understand the safety and effectiveness of these standard of care regimens
Detailed Description:
This study tests the feasibility of using real-world data collection through the recruitment of well-characterized patients into a registry spanning academic and community practice sites to determine patient outcomes in all-comers The scientific community would further benefit from a greater understanding of the safety and effectiveness of newly approved therapies prescribed in routine clinical practice
Non-interventional observational study with 250 participants per exposure group maximum accrual up to 538 total participants comparing outcomes in patients with EGFR-mutated NSCLC not being treated in a clinical trial but receiving standard of care osimertinib - chemotherapy
The treating physician determines whether a patient will receive standard of care single agent osimertinib or osimertinib with chemotherapy and the planned treatment is recorded at registration
ClinicalImaging assessments will be per the treating physician Patient Reported Outcomes PROs will be done 1-3 times per 15 week data capture period
Non-interventional observational study with 250 participants per exposure group maximum accrual up to 538 total participants comparing outcomes in patients with EGFR-mutated NSCLC not being treated in a clinical trial but receiving standard of care osimertinib - chemotherapy
The treating physician determines whether a patient will receive standard of care single agent osimertinib or osimertinib with chemotherapy and the planned treatment is recorded at registration
ClinicalImaging assessments will be per the treating physician Patient Reported Outcomes PROs will be done 1-3 times per 15 week data capture period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None