Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients

Status: Recruiting
Location: See all (117) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arkansas
Mercy Clinic Fort Smith Communities
RECRUITING
Fort Smith
Mercy Research
RECRUITING
Fort Smith
Fowler Family Cancer Center - Jonesboro
RECRUITING
Jonesboro
California
John Muir Health
RECRUITING
Walnut Creek
Washington, D.c.
Sibley Johns Hopkins University
RECRUITING
Washington D.c.
Delaware
Bayhealth
RECRUITING
Dover
Satellite of Bayhealth Sussex
RECRUITING
Milford
Illinois
Advocate Good Shepherd Hospital
RECRUITING
Barrington
Advocate Illinois Masonic Medical Center
RECRUITING
Chicago
John H Stroger Jr Hospital of Cook County
RECRUITING
Chicago
Northwestern University
RECRUITING
Chicago
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Northwestern Medicine Glenview Outpatient Center
RECRUITING
Glenview
Northwestern Medicine Grayslake Outpatient Center
RECRUITING
Grayslake
Advocate South Suburban Hospital
RECRUITING
Hazel Crest
Northwestern Medicine Lake Forest Hospital
RECRUITING
Lake Forest
Advocate Christ Medical Center
RECRUITING
Oak Lawn
Northwestern Medicine Orland Park
RECRUITING
Orland Park
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
Carle Founation Hospital
RECRUITING
Urbana
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Maryland
Greater Baltimore Medical Center
RECRUITING
Baltimore
Minnesota
Minnesota Oncology - Burnsville
RECRUITING
Burnsville
Cambridge Medical Center
RECRUITING
Cambridge
Mercy Hospital
RECRUITING
Coon Rapids
Fairview Southdale Hospital
RECRUITING
Edina
Fairview Clinics and Surgery Center Maple Grove
RECRUITING
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
RECRUITING
Maplewood
Saint John's Hospital - Healtheast
RECRUITING
Maplewood
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
Health Partners Inc.
RECRUITING
Minneapolis
Hennepin County Medical Center
RECRUITING
Minneapolis
Monticello Cancer Center
RECRUITING
Monticello
New Ulm Medical Center
RECRUITING
New Ulm
Fairview Northland Medical Center
RECRUITING
Princeton
North Memorial Medical Health Center
RECRUITING
Robbinsdale
Metro MN
RECRUITING
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Saint Francis Regional Medical Center
RECRUITING
Shakopee
Lakeview Hospital
RECRUITING
Stillwater
Ridgeview Medical Center
RECRUITING
Waconia
Rice Memorial Hospital
RECRUITING
Willmar
Minnesota Oncology Hematology PA-Woodbury
RECRUITING
Woodbury
Fairview Lakes Medical Center
RECRUITING
Wyoming
Missouri
Mercy Clinic Joplin, LLC
RECRUITING
Joplin
Mercy Clinic Cancer and Hematology
RECRUITING
Rolla
Mercy Clinic Springfield Communities
RECRUITING
Springfield
Mercy Clinic East Communities
RECRUITING
St Louis
Mercy Clinic East Communities
RECRUITING
St Louis
Mississippi
Baptist Memorial Hospital and Cancer Center - Golden Triangle
RECRUITING
Columbus
Baptist Cancer Center - Grenada
RECRUITING
Grenada
Jackson Oncology Associates PLLC
RECRUITING
Jackson
Mississippi Baptist Medical Center
RECRUITING
Jackson
Baptist Memorial Hospital and Cancer Center - Union
RECRUITING
New Albany
Baptist Memorial Hospital and Cancer Center - Oxford
RECRUITING
Oxford
Baptist Memorial Hospital and Cancer Center - Desoto
RECRUITING
Southhaven
North Carolina
UNC Pardee Cancer Center
RECRUITING
Hendersonville
New Jersey
Virtua Samson Cancer Center
RECRUITING
Moorestown
Atlantic Health Cancer Consortium Community Oncology Research Program
RECRUITING
Morristown
Morristown Medical Center
RECRUITING
Morristown
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
The Valley Hospital - Luckow Pavilion
RECRUITING
Paramus
Overlook Medical Center
RECRUITING
Summit
Virtua Voorhees
RECRUITING
Voorhees Township
New York
The Cancer Institute at St. Francis Hospital
RECRUITING
East Hills
Montefiore
RECRUITING
New York
SUNY Upstate Medical University
RECRUITING
Syracuse
Montefiore Medical Center-Einstein Campus
RECRUITING
The Bronx
Good Samaritan University Hospital
RECRUITING
West Islip
Ohio
Aultman
RECRUITING
Canton
Miami Valley Hospital South
RECRUITING
Centerville
Miami Valley Hospital North
RECRUITING
Englewood
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Miami Valley Cancer Care and Infusion
RECRUITING
Greenville
Upper Valley Medical Center
RECRUITING
Troy
Oklahoma
Mercy Clinic Oklahoma Communities, Inc.
RECRUITING
Oklahoma City
Pennsylvania
Lankenau Medical Center
RECRUITING
Paoli
University of Pennsylvania
RECRUITING
Philadelphia
Allegheny General Hospital
RECRUITING
Pittsburgh
Tennessee
Baptist Memorial Hospital and Cancer Center - Collierville
RECRUITING
Collierville
Baptist Memorial Hospital and Cancer Center - Memphis
RECRUITING
Memphis
Baptist Memorial Hospital for Women
RECRUITING
Memphis
Texas
UT Southwest
RECRUITING
Dallas
JPS Oncology & Infusion Center
RECRUITING
Fort Worth
Wisconsin
ThedaCare Regional Cancer Center
RECRUITING
Appleton
ThedaCare Regional Medical Center - Appleton
RECRUITING
Appleton
ThedaCare Cancer Care - Berlin
RECRUITING
Berlin
Aurora Cancer Care-Southern Lakes VLCC
RECRUITING
Burlington
Aurora Saint Luke's South Shore
RECRUITING
Cudahy
AHC Germantown Health Center
RECRUITING
Germantown
Aurora Cancer Care-Grafton
RECRUITING
Grafton
Aurora BayCare Medical Center
RECRUITING
Green Bay
Mercyhealth Hospital and Cancer Center - Janesville
RECRUITING
Janesville
Aurora Cancer Care-Kenosha South
RECRUITING
Kenosha
Gundersen Lutheran Medical Foundation
RECRUITING
La Crosse
University of Wisconsin Carbone Cancer Center
RECRUITING
Madison
Aurora Cancer Care-Milwaukee
RECRUITING
Milwaukee
Aurora NCORP
RECRUITING
Milwaukee
Aurora Saint Luke's Medical Center
RECRUITING
Milwaukee
Aurora Sinai Medical Center
RECRUITING
Milwaukee
Aurora West Allis Medical Center
RECRUITING
Milwaukee
ThedaCare Regional Medical Center - Neenah
RECRUITING
Neenah
ThedaCare Cancer Care - New London
RECRUITING
New London
ThedaCare Cancer Care - Oshkosh
RECRUITING
Oshkosh
Vince Lombardi Cancer Clinic-Oshkosh
RECRUITING
Oshkosh
Aurora Cancer Care-Racine
RECRUITING
Racine
ThedaCare Cancer Care - Shawano
RECRUITING
Shawano
Vince Lombardi Cancer Clinic-Sheboygan
RECRUITING
Sheboygan
Aurora Medical Center in Summit
RECRUITING
Summit
Vince Lombardi Cancer Clinic-Two Rivers
RECRUITING
Two Rivers
ProHealth
RECRUITING
Waukesha
ThedaCare Cancer Care - Waupaca
RECRUITING
Waupaca
Aurora Cancer Care-Milwaukee West
RECRUITING
Wauwatosa
Contact Information
Primary
Karen Fitzpatrick, RN
PrE1702@precogllc.org
215-439-2294
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2029-08
Participants
Target number of participants: 538
Treatments
Group 1
Osimertinib
Group 2
Osimertinib + Chemotherapy
Sponsors
Collaborators: ECOG-ACRIN Cancer Research Group
Leads: PrECOG, LLC.

This content was sourced from clinicaltrials.gov