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.
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. Clinical/Imaging assessments will be per the treating physician.
Study Type
OBSERVATIONAL
Enrollment
538
Single agent Osimertinib by mouth once daily. Dosing and administration of osimertinib will be administered as per routine standard of care per the package insert or per institutional guidelines.
Osimertinib by mouth once daily + Chemotherapy. Chemotherapy choice will be per treating physician. Dosing and administration of osimertinib +/- chemotherapy agents will be administered as per routine standard of care per the package insert or per institutional guidelines.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGMercy Clinic Fort Smith Communities
Fort Smith, Arkansas, United States
RECRUITINGMercy Research
Fort Smith, Arkansas, United States
RECRUITINGFowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
real-world Progression-Free Survival (rwPFS)
Time from initiating therapy to progression or death without documented progression
Time frame: From initiation of therapy to progression or death, up to 3 years
real-world Overall Survival (rwOS)
Time from initial therapy to death from any cause.
Time frame: From initiation of therapy to death, up to 3 years
real-world time to treatment discontinuation (rwTTD)
Time from treatment initiation (osimertinib or osimertinib + chemotherapy) to discontinuation of osimertinib.
Time frame: From initiation of therapy to discontinuation of osimertinib, up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stanford Cancer Center Emeryville
Emeryville, California, United States
RECRUITINGStanford Cancer Institute Palo Alto
Palo Alto, California, United States
RECRUITINGStanford Cancer Center South Bay
San Jose, California, United States
RECRUITINGJohn Muir Health
Walnut Creek, California, United States
RECRUITINGBayhealth
Dover, Delaware, United States
RECRUITINGSatellite of Bayhealth Sussex
Milford, Delaware, United States
RECRUITING...and 136 more locations