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NCT06538038Recruiting

Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients

PrECOG, LLC.

Start Date

9/17/2024

Completion Date

8/1/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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.

Interventions

DRUG

Osimertinib

DRUG

Osimertinib + Chemotherapy

Interested in This Trial?

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Conditions

Non Small Cell Lung CancerEpidermal Growth Factor Receptor Gene MutationStage III Lung CancerStage IV Lung Cancer

Locations

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