Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients
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. Clinical/Imaging assessments will be per the treating physician.
Arms & interventions
- DrugOsimertinib
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.
- DrugOsimertinib + Chemotherapy
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.
Outcome measures
Primary
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
Secondary
real-world Overall Survival (rwOS)
Time frame: From initiation of therapy to death, up to 3 years
real-world time to treatment discontinuation (rwTTD)
Time frame: From initiation of therapy to discontinuation of osimertinib, up to 3 years
Eligibility criteria
Study locations (146)
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Mercy Clinic Fort Smith Communities
Fort Smith, Arkansas, 72903
Mercy Research
Fort Smith, Arkansas, 72903
Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Stanford Cancer Center Emeryville
Emeryville, California, 94608
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Stanford Cancer Center South Bay
San Jose, California, 95124
John Muir Health
Walnut Creek, California, 94598
Bayhealth
Dover, Delaware, 19901
Satellite of Bayhealth Sussex
Milford, Delaware, 19901
Sibley Johns Hopkins University
Washington D.C., District of Columbia, 20016
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Liberty County Cancer Care
Hinesville, Georgia, 31313
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Regional Cancer Care
Jesup, Georgia, 31545
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Northwestern University
Chicago, Illinois, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Carle Cancer Institute Normal
Normal, Illinois, 61761
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Carle Founation Hospital
Urbana, Illinois, 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Tufts Medical Center
Boston, Massachusetts, 02111
Lowell General Hosptial
Lowell, Massachusetts, 01854
Tufts Medical Center Cancer Center Stoneham
Stoneham, Massachusetts, 02180
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Cambridge Medical Center
Cambridge, Minnesota, 55008
Mercy Hospital
Coon Rapids, Minnesota, 55433
Fairview Southdale Hospital
Edina, Minnesota, 55435
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Health Partners Inc.
Minneapolis, Minnesota, 55454
Monticello Cancer Center
Monticello, Minnesota, 55362
New Ulm Medical Center
New Ulm, Minnesota, 56073
Fairview Northland Medical Center
Princeton, Minnesota, 55371
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Metro MN
Saint Louis Park, Minnesota, 55426
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Lakeview Hospital
Stillwater, Minnesota, 55082
Ridgeview Medical Center
Waconia, Minnesota, 55387
Rice Memorial Hospital
Willmar, Minnesota, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
Baptist Memorial Hospital and Cancer Center - Golden Triangle
Columbus, Mississippi, 39705
Baptist Cancer Center - Grenada
Grenada, Mississippi, 38901
Jackson Oncology Associates PLLC
Jackson, Mississippi, 39202
Mississippi Baptist Medical Center
Jackson, Mississippi, 39202
Baptist Memorial Hospital and Cancer Center - Union
New Albany, Mississippi, 38652
Baptist Memorial Hospital and Cancer Center - Oxford
Oxford, Mississippi, 38655
Baptist Memorial Hospital and Cancer Center - Desoto
Southhaven, Mississippi, 38671
Mercy Clinic Joplin, LLC
Joplin, Missouri, 64804
Mercy Clinic Cancer and Hematology
Rolla, Missouri, 65401
Mercy Clinic Springfield Communities
Springfield, Missouri, 65804
Mercy Clinic East Communities
St Louis, Missouri, 63128
Mercy Clinic East Communities
St Louis, Missouri, 63141
Virtua Samson Cancer Center
Moorestown, New Jersey, 08057
Atlantic Health Cancer Consortium Community Oncology Research Program
Morristown, New Jersey, 07960
Morristown Medical Center
Morristown, New Jersey, 07960
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080
Overlook Medical Center
Summit, New Jersey, 07901
Virtua Voorhees
Voorhees Township, New Jersey, 08043
The Cancer Institute at St. Francis Hospital
East Hills, New York, 11548
Montefiore
New York, New York, 10467
SUNY Upstate Medical University
Syracuse, New York, 13210
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Good Samaritan University Hospital
West Islip, New York, 11795
UNC Pardee Cancer Center
Hendersonville, North Carolina, 28791
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Aultman
Canton, Ohio, 44710
Miami Valley Hospital South
Centerville, Ohio, 45459
Miami Valley Hospital North
Englewood, Ohio, 45415
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Upper Valley Medical Center
Troy, Ohio, 45373
Mercy Clinic Oklahoma Communities, Inc.
Oklahoma City, Oklahoma, 73120
Geisinger Medical Center
Danville, Pennsylvania, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Lewistown Hospital
Lewistown, Pennsylvania, 17044
Lankenau Medical Center
Paoli, Pennsylvania, 19301
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
Community Medical Center
Scranton, Pennsylvania, 18510
Geisinger Medical Group
State College, Pennsylvania, 16801
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: SJC Bluffton Campus
Bluffton, South Carolina, 29910
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: South Carolina Cancer Specialists
Hilton Head Island, South Carolina, 29926
Baptist Memorial Hospital and Cancer Center - Collierville
Collierville, Tennessee, 38017
Baptist Memorial Hospital and Cancer Center - Memphis
Memphis, Tennessee, 38120
Baptist Memorial Hospital for Women
Memphis, Tennessee, 38120
Vanderbilt University
Nashville, Tennessee, 37232
UT Southwest
Dallas, Texas, 75235
JPS Oncology & Infusion Center
Fort Worth, Texas, 76104
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
ThedaCare Regional Medical Center - Appleton
Appleton, Wisconsin, 54911
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
AHC Germantown Health Center
Germantown, Wisconsin, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53715
Marshfield Medical Center
Marshfield, Wisconsin, 54449
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Aurora NCORP
Milwaukee, Wisconsin, 53215
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Aurora West Allis Medical Center
Milwaukee, Wisconsin, 53227
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin, 54956
ThedaCare Cancer Care - New London
New London, Wisconsin, 54961
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin, 54904
Vince Lombardi Cancer Clinic-Oshkosh
Oshkosh, Wisconsin, 54904
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin, 54166
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
ProHealth
Waukesha, Wisconsin, 53022
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin, 54981
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226