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Non Small Cell Lung CancerNCT06538038

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

An observational study of Non Small Cell Lung Cancer and Epidermal Growth Factor Receptor Gene Mutation, run by PrECOG, LLC. at 146 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Osimertinib and Osimertinib + Chemotherapy
Type of treatment
Pill or oral medicine
How many people
200 participants
Where
146 sitesUnited States
Study dates
17 Sep 2024to Aug 2029
How long will I take part?
3 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

146 sites in 1 country.

146 sites in 1 country

United States146 sites

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • ThedaCare Regional Medical Center - Appleton

    Appleton, Wisconsin, 54911

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

  • ThedaCare Cancer Care - Berlin

    Berlin, Wisconsin, 54923

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

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

    Bluffton, South Carolina, 29910

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Aultman

    Canton, Ohio, 44710

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Baptist Memorial Hospital and Cancer Center - Collierville

    Collierville, Tennessee, 38017

  • Baptist Memorial Hospital and Cancer Center - Golden Triangle

    Columbus, Mississippi, 39705

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

  • UT Southwest

    Dallas, Texas, 75235

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Bayhealth

    Dover, Delaware, 19901

  • The Cancer Institute at St. Francis Hospital

    East Hills, New York, 11548

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Stanford Cancer Center Emeryville

    Emeryville, California, 94608

  • Miami Valley Hospital North

    Englewood, Ohio, 45415

  • Mercy Clinic Fort Smith Communities

    Fort Smith, Arkansas, 72903

  • Mercy Research

    Fort Smith, Arkansas, 72903

  • JPS Oncology & Infusion Center

    Fort Worth, Texas, 76104

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • AHC Germantown Health Center

    Germantown, Wisconsin, 53022

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

  • Baptist Cancer Center - Grenada

    Grenada, Mississippi, 38901

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • UNC Pardee Cancer Center

    Hendersonville, North Carolina, 28791

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

    Hilton Head Island, South Carolina, 29926

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

    Hinesville, Georgia, 31313

  • Jackson Oncology Associates PLLC

    Jackson, Mississippi, 39202

  • Mississippi Baptist Medical Center

    Jackson, Mississippi, 39202

  • Mercyhealth Hospital and Cancer Center - Janesville

    Janesville, Wisconsin, 53548

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

    Jesup, Georgia, 31545

  • Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Mercy Clinic Joplin, LLC

    Joplin, Missouri, 64804

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Gundersen Lutheran Medical Foundation

    La Crosse, Wisconsin, 54601

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Lowell General Hosptial

    Lowell, Massachusetts, 01854

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53715

  • 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

  • Marshfield Medical Center

    Marshfield, Wisconsin, 54449

  • Baptist Memorial Hospital and Cancer Center - Memphis

    Memphis, Tennessee, 38120

  • Baptist Memorial Hospital for Women

    Memphis, Tennessee, 38120

  • Satellite of Bayhealth Sussex

    Milford, Delaware, 19901

  • 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

  • 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

  • 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

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • ThedaCare Regional Medical Center - Neenah

    Neenah, Wisconsin, 54956

  • Baptist Memorial Hospital and Cancer Center - Union

    New Albany, Mississippi, 38652

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • ThedaCare Cancer Care - New London

    New London, Wisconsin, 54961

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Montefiore

    New York, New York, 10467

  • Carle Cancer Institute Normal

    Normal, Illinois, 61761

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Mercy Clinic Oklahoma Communities, Inc.

    Oklahoma City, Oklahoma, 73120

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

  • ThedaCare Cancer Care - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Vince Lombardi Cancer Clinic-Oshkosh

    Oshkosh, Wisconsin, 54904

  • Baptist Memorial Hospital and Cancer Center - Oxford

    Oxford, Mississippi, 38655

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Lankenau Medical Center

    Paoli, Pennsylvania, 19301

  • The Valley Hospital - Luckow Pavilion

    Paramus, New Jersey, 07652

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • 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

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mercy Clinic Cancer and Hematology

    Rolla, Missouri, 65401

  • 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

  • Stanford Cancer Center South Bay

    San Jose, California, 95124

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

    Savannah, Georgia, 31405

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • Sidney Kimmel Cancer Center Washington Township

    Sewell, New Jersey, 08080

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • ThedaCare Cancer Care - Shawano

    Shawano, Wisconsin, 54166

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Baptist Memorial Hospital and Cancer Center - Desoto

    Southhaven, Mississippi, 38671

  • Mercy Clinic Springfield Communities

    Springfield, Missouri, 65804

  • Mercy Clinic East Communities

    St Louis, Missouri, 63128

  • Mercy Clinic East Communities

    St Louis, Missouri, 63141

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Tufts Medical Center Cancer Center Stoneham

    Stoneham, Massachusetts, 02180

  • Overlook Medical Center

    Summit, New Jersey, 07901

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • Carle Founation Hospital

    Urbana, Illinois, 61801

  • Virtua Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • John Muir Health

    Walnut Creek, California, 94598

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • Sibley Johns Hopkins University

    Washington D.C., District of Columbia, 20016

  • ProHealth

    Waukesha, Wisconsin, 53022

  • ThedaCare Cancer Care - Waupaca

    Waupaca, Wisconsin, 54981

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Good Samaritan University Hospital

    West Islip, New York, 11795

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Osimertinib, Osimertinib + Chemotherapy
Keywords
Osimertinib, Cisplatin, Carboplatin, Pemetrexed, EGFR Mutated
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OsimertinibDrug

    Also called Tagrisso

    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 + ChemotherapyDrug

    Also called Tagrisso, Cisplatin, Carboplatin, Pemetrexed

    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.

Study groups in NCT06538038
Study groupRoleWhat they receive
Group 1Osimertinib
Receives: Drug: Osimertinib
Group 2Osimertinib + Chemotherapy
Receives: Drug: Osimertinib + Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. real-world Progression-Free Survival (rwPFS)

    Time from initiating therapy to progression or death without documented progression

    Measured: From initiation of therapy to progression or death, up to 3 years

Secondary outcomes (2)

  1. real-world Overall Survival (rwOS)

    Time from initial therapy to death from any cause.

    Measured: From initiation of therapy to death, up to 3 years

  2. real-world time to treatment discontinuation (rwTTD)

    Time from treatment initiation (osimertinib or osimertinib + chemotherapy) to discontinuation of osimertinib.

    Measured: From initiation of therapy to discontinuation of osimertinib, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2024
  2. Study start17 Sep 2024
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538038
Sponsor's protocol ID
PrE1702
Status last verified
Sep 2026
First submitted
31 Jul 2024
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data is proprietary.

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