Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
1 other identifier
observational
538
1 country
146
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Longer than P75 for all trials
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2024
CompletedFirst Posted
Study publicly available on registry
August 5, 2024
CompletedStudy Start
First participant enrolled
September 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
March 27, 2026
March 1, 2026
3.9 years
July 31, 2024
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
real-world Progression-Free Survival (rwPFS)
Time from initiating therapy to progression or death without documented progression
From initiation of therapy to progression or death, up to 3 years
Secondary Outcomes (2)
real-world Overall Survival (rwOS)
From initiation of therapy to death, up to 3 years
real-world time to treatment discontinuation (rwTTD)
From initiation of therapy to discontinuation of osimertinib, up to 3 years
Study Arms (2)
Group 1
Osimertinib
Group 2
Osimertinib + Chemotherapy
Interventions
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.
Eligibility Criteria
Patients with EGFR-mutated NSCLC, not being treated in a clinical trial but receiving osimertinib +/- chemotherapy at academic and community practices participating in PrE1702 registry.
You may qualify if:
- Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).
- Patient must have advanced disease, defined as IIIB (not amenable to definitive multi-modality therapy), IIIC, or IV (includes local or distant recurrent disease after a prior diagnosis of Stage I-III disease). All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria.
- Patient tumor must have somatic activating sensitizing mutation in EGFR (e.g., but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Plasma, cytology, or tumor tissue can be utilized for standard of care mutation testing.
- Prior chemotherapy and/or immunotherapy administered as primary treatment for NSCLC before EGFR mutation was identified is allowed ≤ 45 days of study registration to allow for return of sequencing information.
- Prior treatment with osimertinib administered as primary treatment for NSCLC is allowed ≤ 30 days of study registration (prior treatment with any other EGFR TKI agent is not allowed).
- Patient must not be participating in EA5182 or any other cancer treatment trial. Osimertinib or osimertinib + chemotherapy/immunotherapy given as first-line treatment for this disease cannot be given as part of a clinical trial.
- Patients that have received prior radiation therapy in any setting for this disease are eligible.
- Adults age ≥ 18 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PrECOG, LLC.lead
- ECOG-ACRIN Cancer Research Groupcollaborator
Study Sites (146)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mercy Clinic Fort Smith Communities
Fort Smith, Arkansas, 72903, United States
Mercy Research
Fort Smith, Arkansas, 72903, United States
Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
Stanford Cancer Center Emeryville
Emeryville, California, 94608, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Stanford Cancer Center South Bay
San Jose, California, 95124, United States
John Muir Health
Walnut Creek, California, 94598, United States
Bayhealth
Dover, Delaware, 19901, United States
Satellite of Bayhealth Sussex
Milford, Delaware, 19901, United States
Sibley Johns Hopkins University
Washington D.C., District of Columbia, 20016, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Liberty County Cancer Care
Hinesville, Georgia, 31313, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Regional Cancer Care
Jesup, Georgia, 31545, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, United States
Northwestern University
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Carle Founation Hospital
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Lowell General Hosptial
Lowell, Massachusetts, 01854, United States
Tufts Medical Center Cancer Center Stoneham
Stoneham, Massachusetts, 02180, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc.
Minneapolis, Minnesota, 55454, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Metro MN
Saint Louis Park, Minnesota, 55426, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
Baptist Memorial Hospital and Cancer Center - Golden Triangle
Columbus, Mississippi, 39705, United States
Baptist Cancer Center - Grenada
Grenada, Mississippi, 38901, United States
Jackson Oncology Associates PLLC
Jackson, Mississippi, 39202, United States
Mississippi Baptist Medical Center
Jackson, Mississippi, 39202, United States
Baptist Memorial Hospital and Cancer Center - Union
New Albany, Mississippi, 38652, United States
Baptist Memorial Hospital and Cancer Center - Oxford
Oxford, Mississippi, 38655, United States
Baptist Memorial Hospital and Cancer Center - Desoto
Southhaven, Mississippi, 38671, United States
Mercy Clinic Joplin, LLC
Joplin, Missouri, 64804, United States
Mercy Clinic Cancer and Hematology
Rolla, Missouri, 65401, United States
Mercy Clinic Springfield Communities
Springfield, Missouri, 65804, United States
Mercy Clinic East Communities
St Louis, Missouri, 63128, United States
Mercy Clinic East Communities
St Louis, Missouri, 63141, United States
Virtua Samson Cancer Center
Moorestown, New Jersey, 08057, United States
Atlantic Health Cancer Consortium Community Oncology Research Program
Morristown, New Jersey, 07960, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
The Cancer Institute at St. Francis Hospital
East Hills, New York, 11548, United States
Montefiore
New York, New York, 10467, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Good Samaritan University Hospital
West Islip, New York, 11795, United States
UNC Pardee Cancer Center
Hendersonville, North Carolina, 28791, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Aultman
Canton, Ohio, 44710, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Miami Valley Hospital North
Englewood, Ohio, 45415, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Mercy Clinic Oklahoma Communities, Inc.
Oklahoma City, Oklahoma, 73120, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Lankenau Medical Center
Paoli, Pennsylvania, 19301, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: SJC Bluffton Campus
Bluffton, South Carolina, 29910, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: South Carolina Cancer Specialists
Hilton Head Island, South Carolina, 29926, United States
Baptist Memorial Hospital and Cancer Center - Collierville
Collierville, Tennessee, 38017, United States
Baptist Memorial Hospital and Cancer Center - Memphis
Memphis, Tennessee, 38120, United States
Baptist Memorial Hospital for Women
Memphis, Tennessee, 38120, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
UT Southwest
Dallas, Texas, 75235, United States
JPS Oncology & Infusion Center
Fort Worth, Texas, 76104, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
ThedaCare Regional Medical Center - Appleton
Appleton, Wisconsin, 54911, United States
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110, United States
AHC Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53715, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Aurora NCORP
Milwaukee, Wisconsin, 53215, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Aurora West Allis Medical Center
Milwaukee, Wisconsin, 53227, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin, 54956, United States
ThedaCare Cancer Care - New London
New London, Wisconsin, 54961, United States
ThedaCare Cancer Care - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic-Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
ThedaCare Cancer Care - Shawano
Shawano, Wisconsin, 54166, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
ProHealth
Waukesha, Wisconsin, 53022, United States
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin, 54981, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Suzanne Cole, MD
UT Southwestern Simmons Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2024
First Posted
August 5, 2024
Study Start
September 17, 2024
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2029
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Data is proprietary.