Recruiting

Osimertinib & Chemotherapy

Sponsor:

PrECOG, LLC.

Code:

NCT06538038

Conditions

Non Small Cell Lung Cancer

Epidermal Growth Factor Receptor Gene Mutation

Stage III Lung Cancer

Stage IV Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Osimertinib

Osimertinib + Chemotherapy

Study Details

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.

Conditions

Non Small Cell Lung Cancer

Epidermal Growth Factor Receptor Gene Mutation

Stage III Lung Cancer

Stage IV Lung Cancer

Study ID

NCT06538038

Start date

Sep 17, 2024

Status verified date

Mar, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

538 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Osimertinib

Group 2

Osimertinib + Chemotherapy

Interventions

Osimertinib

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 + 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.

Primary outcome measure

  • real-world Progression-Free Survival (rwPFS) [ Time Frame: From initiation of therapy to progression or death, up to 3 years ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Mercy Clinic Fort Smith Communities

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Mercy Research

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Fowler Family Cancer Center - Jonesboro

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Stanford Cancer Center Emeryville

Recruiting

Emeryville, California, United States, 94608

Contacts

Stanford Cancer Institute Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

Stanford Cancer Center South Bay

Recruiting

San Jose, California, United States, 95124

Contacts

John Muir Health

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Bayhealth

Recruiting

Dover, Delaware, United States, 19901

Contacts

Satellite of Bayhealth Sussex

Recruiting

Milford, Delaware, United States, 19901

Contacts

Sibley Johns Hopkins University

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Liberty County Cancer Care

Recruiting

Hinesville, Georgia, United States, 31313

Contacts

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Regional Cancer Care

Recruiting

Jesup, Georgia, United States, 31545

Contacts

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Advocate Good Shepherd Hospital

Recruiting

Barrington, Illinois, United States, 60010

Contacts

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

John H Stroger Jr Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Advocate Illinois Masonic Medical Center

Recruiting

Chicago, Illinois, United States, 60657

Contacts

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Northwestern Medicine Glenview Outpatient Center

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Northwestern Medicine Grayslake Outpatient Center

Recruiting

Grayslake, Illinois, United States, 60030

Contacts

Advocate South Suburban Hospital

Recruiting

Hazel Crest, Illinois, United States, 60429

Contacts

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Carle Cancer Institute Normal

Recruiting

Normal, Illinois, United States, 61761

Contacts

Advocate Christ Medical Center

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Advocate Lutheran General Hospital

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Carle Founation Hospital

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

University of Maryland Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Greater Baltimore Medical Center

Recruiting

Baltimore, Maryland, United States, 21204

Contacts

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Lowell General Hosptial

Recruiting

Lowell, Massachusetts, United States, 01854

Contacts

Tufts Medical Center Cancer Center Stoneham

Recruiting

Stoneham, Massachusetts, United States, 02180

Contacts

Minnesota Oncology - Burnsville

Recruiting

Burnsville, Minnesota, United States, 55337

Contacts

Cambridge Medical Center

Recruiting

Cambridge, Minnesota, United States, 55008

Contacts

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Fairview Clinics and Surgery Center Maple Grove

Recruiting

Maple Grove, Minnesota, United States, 55369

Contacts

Minnesota Oncology Hematology PA-Maplewood

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Health Partners Inc.

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Monticello Cancer Center

Recruiting

Monticello, Minnesota, United States, 55362

Contacts

New Ulm Medical Center

Recruiting

New Ulm, Minnesota, United States, 56073

Contacts

Fairview Northland Medical Center

Recruiting

Princeton, Minnesota, United States, 55371

Contacts

North Memorial Medical Health Center

Recruiting

Robbinsdale, Minnesota, United States, 55422

Contacts

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Metro MN

Recruiting

Saint Louis Park, Minnesota, United States, 55426

Contacts

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Saint Francis Regional Medical Center

Recruiting

Shakopee, Minnesota, United States, 55379

Contacts

Lakeview Hospital

Recruiting

Stillwater, Minnesota, United States, 55082

Contacts

Ridgeview Medical Center

Recruiting

Waconia, Minnesota, United States, 55387

Contacts

Rice Memorial Hospital

Recruiting

Willmar, Minnesota, United States, 56201

Contacts

Minnesota Oncology Hematology PA-Woodbury

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Fairview Lakes Medical Center

Recruiting

Wyoming, Minnesota, United States, 55092

Contacts

Baptist Memorial Hospital and Cancer Center - Golden Triangle

Recruiting

Columbus, Mississippi, United States, 39705

Contacts

Baptist Cancer Center - Grenada

Recruiting

Grenada, Mississippi, United States, 38901

Contacts

Jackson Oncology Associates PLLC

Recruiting

Jackson, Mississippi, United States, 39202

Contacts

Mississippi Baptist Medical Center

Recruiting

Jackson, Mississippi, United States, 39202

Contacts

Baptist Memorial Hospital and Cancer Center - Union

Recruiting

New Albany, Mississippi, United States, 38652

Contacts

Baptist Memorial Hospital and Cancer Center - Oxford

Recruiting

Oxford, Mississippi, United States, 38655

Contacts

Baptist Memorial Hospital and Cancer Center - Desoto

Recruiting

Southhaven, Mississippi, United States, 38671

Contacts

Mercy Clinic Joplin, LLC

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Mercy Clinic Cancer and Hematology

Recruiting

Rolla, Missouri, United States, 65401

Contacts

Mercy Clinic Springfield Communities

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Mercy Clinic East Communities

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Mercy Clinic East Communities

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Virtua Samson Cancer Center

Recruiting

Moorestown, New Jersey, United States, 08057

Contacts

Atlantic Health Cancer Consortium Community Oncology Research Program

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

The Valley Hospital - Luckow Pavilion

Recruiting

Paramus, New Jersey, United States, 07652

Contacts

Sidney Kimmel Cancer Center Washington Township

Recruiting

Sewell, New Jersey, United States, 08080

Contacts

Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Virtua Voorhees

Recruiting

Voorhees Township, New Jersey, United States, 08043

Contacts

The Cancer Institute at St. Francis Hospital

Recruiting

East Hills, New York, United States, 11548

Contacts

Montefiore

Recruiting

New York, New York, United States, 10467

Contacts

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Montefiore Medical Center-Einstein Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

Good Samaritan University Hospital

Recruiting

West Islip, New York, United States, 11795

Contacts

UNC Pardee Cancer Center

Recruiting

Hendersonville, North Carolina, United States, 28791

Contacts

FirstHealth of the Carolinas-Moore Regional Hospital

Recruiting

Pinehurst, North Carolina, United States, 28374

Contacts

Aultman

Recruiting

Canton, Ohio, United States, 44710

Contacts

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Miami Valley Hospital North

Recruiting

Englewood, Ohio, United States, 45415

Contacts

Atrium Medical Center-Middletown Regional Hospital

Recruiting

Franklin, Ohio, United States, 45005

Contacts

Miami Valley Cancer Care and Infusion

Recruiting

Greenville, Ohio, United States, 45331

Contacts

Upper Valley Medical Center

Recruiting

Troy, Ohio, United States, 45373

Contacts

Mercy Clinic Oklahoma Communities, Inc.

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Geisinger Medical Center-Cancer Center Hazleton

Recruiting

Hazleton, Pennsylvania, United States, 18201

Contacts

Geisinger Medical Oncology-Lewisburg

Recruiting

Lewisburg, Pennsylvania, United States, 17837

Contacts

Lewistown Hospital

Recruiting

Lewistown, Pennsylvania, United States, 17044

Contacts

Lankenau Medical Center

Recruiting

Paoli, Pennsylvania, United States, 19301

Contacts

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Jefferson Torresdale Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Contacts

Einstein Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contacts

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Geisinger Cancer Services-Pottsville

Recruiting

Pottsville, Pennsylvania, United States, 17901

Contacts

Community Medical Center

Recruiting

Scranton, Pennsylvania, United States, 18510

Contacts

Geisinger Medical Group

Recruiting

State College, Pennsylvania, United States, 16801

Contacts

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Asplundh Cancer Pavilion

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: SJC Bluffton Campus

Recruiting

Bluffton, South Carolina, United States, 29910

Contacts

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: South Carolina Cancer Specialists

Recruiting

Hilton Head Island, South Carolina, United States, 29926

Contacts

Baptist Memorial Hospital and Cancer Center - Collierville

Recruiting

Collierville, Tennessee, United States, 38017

Contacts

Baptist Memorial Hospital and Cancer Center - Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Baptist Memorial Hospital for Women

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

UT Southwest

Recruiting

Dallas, Texas, United States, 75235

Contacts

JPS Oncology & Infusion Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

ThedaCare Regional Medical Center - Appleton

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

ThedaCare Cancer Care - Berlin

Recruiting

Berlin, Wisconsin, United States, 54923

Contacts

Aurora Cancer Care-Southern Lakes VLCC

Recruiting

Burlington, Wisconsin, United States, 53105

Contacts

Aurora Saint Luke's South Shore

Recruiting

Cudahy, Wisconsin, United States, 53110

Contacts

AHC Germantown Health Center

Recruiting

Germantown, Wisconsin, United States, 53022

Contacts

Aurora Cancer Care-Grafton

Recruiting

Grafton, Wisconsin, United States, 53024

Contacts

Aurora BayCare Medical Center

Recruiting

Green Bay, Wisconsin, United States, 54311

Contacts

Mercyhealth Hospital and Cancer Center - Janesville

Recruiting

Janesville, Wisconsin, United States, 53548

Contacts

Aurora Cancer Care-Kenosha South

Recruiting

Kenosha, Wisconsin, United States, 53142

Contacts

Gundersen Lutheran Medical Foundation

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Marshfield Medical Center

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Aurora Cancer Care-Milwaukee

Recruiting

Milwaukee, Wisconsin, United States, 53209

Contacts

Aurora NCORP

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Aurora Saint Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Aurora West Allis Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53227

Contacts

Aurora Sinai Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

ThedaCare Regional Medical Center - Neenah

Recruiting

Neenah, Wisconsin, United States, 54956

Contacts

ThedaCare Cancer Care - New London

Recruiting

New London, Wisconsin, United States, 54961

Contacts

ThedaCare Cancer Care - Oshkosh

Recruiting

Oshkosh, Wisconsin, United States, 54904

Contacts

Vince Lombardi Cancer Clinic-Oshkosh

Recruiting

Oshkosh, Wisconsin, United States, 54904

Contacts

Aurora Cancer Care-Racine

Recruiting

Racine, Wisconsin, United States, 53406

Contacts

ThedaCare Cancer Care - Shawano

Recruiting

Shawano, Wisconsin, United States, 54166

Contacts

Vince Lombardi Cancer Clinic-Sheboygan

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Aurora Medical Center in Summit

Recruiting

Summit, Wisconsin, United States, 53066

Contacts

Vince Lombardi Cancer Clinic-Two Rivers

Recruiting

Two Rivers, Wisconsin, United States, 54241

Contacts

ProHealth

Recruiting

Waukesha, Wisconsin, United States, 53022

Contacts

ThedaCare Cancer Care - Waupaca

Recruiting

Waupaca, Wisconsin, United States, 54981

Contacts

Aurora Cancer Care-Milwaukee West

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contacts

More Information

Sponsor

PrECOG, LLC.

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Osimertinib
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • EGFR Mutated

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by PrECOG, LLC. on 2026-03-27.