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

March 26, 2026 updated by: PrECOG, LLC.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

538

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Clinic Fort Smith Communities
        • Contact:
      • Fort Smith, Arkansas, United States, 72903
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • Fowler Family Cancer Center - Jonesboro
        • Contact:
    • California
      • Emeryville, California, United States, 94608
        • Recruiting
        • Stanford Cancer Center Emeryville
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute Palo Alto
        • Contact:
      • San Jose, California, United States, 95124
        • Recruiting
        • Stanford Cancer Center South Bay
        • Contact:
      • Walnut Creek, California, United States, 94598
    • Delaware
      • Dover, Delaware, United States, 19901
      • Milford, Delaware, United States, 19901
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Sibley Johns Hopkins University
        • Contact:
    • Georgia
      • Hinesville, Georgia, United States, 31313
        • Recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Liberty County Cancer Care
        • Contact:
      • Jesup, Georgia, United States, 31545
        • Recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Regional Cancer Care
        • Contact:
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
        • Contact:
    • Illinois
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Advocate Good Shepherd Hospital
        • Contact:
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • John H Stroger Jr Hospital of Cook County
        • Contact:
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
      • DeKalb, Illinois, United States, 60115
      • Geneva, Illinois, United States, 60134
      • Glenview, Illinois, United States, 60026
      • Grayslake, Illinois, United States, 60030
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Advocate South Suburban Hospital
        • Contact:
      • Lake Forest, Illinois, United States, 60045
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle Cancer Institute Normal
        • Contact:
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
      • Orland Park, Illinois, United States, 60462
      • Park Ridge, Illinois, United States, 60068
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Founation Hospital
        • Contact:
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Greater Baltimore Medical Center
        • Contact:
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Greenebaum Comprehensive Cancer Center
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Lowell, Massachusetts, United States, 01854
      • Stoneham, Massachusetts, United States, 02180
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
      • Cambridge, Minnesota, United States, 55008
      • Coon Rapids, Minnesota, United States, 55433
      • Edina, Minnesota, United States, 55435
      • Maple Grove, Minnesota, United States, 55369
      • Maplewood, Minnesota, United States, 55109
      • Maplewood, Minnesota, United States, 55109
      • Minneapolis, Minnesota, United States, 55407
      • Minneapolis, Minnesota, United States, 55415
      • Minneapolis, Minnesota, United States, 55454
      • Monticello, Minnesota, United States, 55362
      • New Ulm, Minnesota, United States, 56073
      • Princeton, Minnesota, United States, 55371
      • Robbinsdale, Minnesota, United States, 55422
      • Saint Louis Park, Minnesota, United States, 55416
      • Saint Louis Park, Minnesota, United States, 55426
      • Saint Paul, Minnesota, United States, 55101
      • Saint Paul, Minnesota, United States, 55102
      • Shakopee, Minnesota, United States, 55379
      • Stillwater, Minnesota, United States, 55082
      • Waconia, Minnesota, United States, 55387
      • Willmar, Minnesota, United States, 56201
      • Woodbury, Minnesota, United States, 55125
      • Wyoming, Minnesota, United States, 55092
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center - Golden Triangle
        • Contact:
      • Grenada, Mississippi, United States, 38901
        • Recruiting
        • Baptist Cancer Center - Grenada
        • Contact:
      • Jackson, Mississippi, United States, 39202
        • Recruiting
        • Mississippi Baptist Medical Center
        • Contact:
      • Jackson, Mississippi, United States, 39202
        • Recruiting
        • Jackson Oncology Associates PLLC
        • Contact:
      • New Albany, Mississippi, United States, 38652
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center - Union
        • Contact:
      • Oxford, Mississippi, United States, 38655
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center - Oxford
        • Contact:
      • Southhaven, Mississippi, United States, 38671
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center - Desoto
        • Contact:
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Clinic Joplin, LLC
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic Cancer and Hematology
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Clinic Springfield Communities
        • Contact:
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Clinic East Communities
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Clinic East Communities
        • Contact:
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Recruiting
        • Virtua Samson Cancer Center
        • Contact:
      • Morristown, New Jersey, United States, 07960
      • Morristown, New Jersey, United States, 07960
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
      • Paramus, New Jersey, United States, 07652
        • Recruiting
        • The Valley Hospital - Luckow Pavilion
        • Contact:
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Sidney Kimmel Cancer Center Washington Township
        • Contact:
      • Summit, New Jersey, United States, 07901
      • Voorhees Township, New Jersey, United States, 08043
        • Recruiting
        • Virtua Voorhees
        • Contact:
    • New York
      • East Hills, New York, United States, 11548
        • Recruiting
        • The Cancer Institute at St. Francis Hospital
        • Contact:
      • New York, New York, United States, 10467
        • Recruiting
        • Montefiore
        • Contact:
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
        • Contact:
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Einstein Campus
        • Contact:
      • West Islip, New York, United States, 11795
        • Recruiting
        • Good Samaritan University Hospital
        • Contact:
    • North Carolina
      • Hendersonville, North Carolina, United States, 28791
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44710
      • Centerville, Ohio, United States, 45459
      • Englewood, Ohio, United States, 45415
      • Franklin, Ohio, United States, 45005
        • Recruiting
        • Atrium Medical Center-Middletown Regional Hospital
        • Contact:
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Miami Valley Cancer Care and Infusion
        • Contact:
      • Troy, Ohio, United States, 45373
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Clinic Oklahoma Communities, Inc.
        • Contact:
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
      • Hazleton, Pennsylvania, United States, 18201
        • Recruiting
        • Geisinger Medical Center-Cancer Center Hazleton
        • Contact:
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
      • Lewistown, Pennsylvania, United States, 17044
      • Paoli, Pennsylvania, United States, 19301
        • Recruiting
        • Lankenau Medical Center
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19114
      • Philadelphia, Pennsylvania, United States, 19141
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
      • Pottsville, Pennsylvania, United States, 17901
        • Recruiting
        • Geisinger Cancer Services-Pottsville
        • Contact:
      • Scranton, Pennsylvania, United States, 18510
      • State College, Pennsylvania, United States, 16801
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
      • Willow Grove, Pennsylvania, United States, 19090
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: SJC Bluffton Campus
        • Contact:
      • Hilton Head Island, South Carolina, United States, 29926
        • Recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: South Carolina Cancer Specialists
        • Contact:
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center - Collierville
        • Contact:
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital for Women
        • Contact:
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center - Memphis
        • Contact:
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75235
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • JPS Oncology & Infusion Center
        • Contact:
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Medical Center - Appleton
        • Contact:
      • Berlin, Wisconsin, United States, 54923
      • Burlington, Wisconsin, United States, 53105
        • Recruiting
        • Aurora Cancer Care-Southern Lakes VLCC
        • Contact:
      • Cudahy, Wisconsin, United States, 53110
        • Recruiting
        • Aurora Saint Luke's South Shore
        • Contact:
      • Germantown, Wisconsin, United States, 53022
        • Recruiting
        • AHC Germantown Health Center
        • Contact:
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Contact:
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
      • Janesville, Wisconsin, United States, 53548
        • Recruiting
        • Mercyhealth Hospital and Cancer Center - Janesville
        • Contact:
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Aurora Cancer Care-Kenosha South
        • Contact:
      • La Crosse, Wisconsin, United States, 54601
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Contact:
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53209
        • Recruiting
        • Aurora Cancer Care-Milwaukee
        • Contact:
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
      • Milwaukee, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
      • Milwaukee, Wisconsin, United States, 53215
      • Neenah, Wisconsin, United States, 54956
        • Recruiting
        • ThedaCare Regional Medical Center - Neenah
        • Contact:
      • New London, Wisconsin, United States, 54961
      • Oshkosh, Wisconsin, United States, 54904
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic-Oshkosh
        • Contact:
      • Racine, Wisconsin, United States, 53406
      • Shawano, Wisconsin, United States, 54166
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
      • Summit, Wisconsin, United States, 53066
        • Recruiting
        • Aurora Medical Center in Summit
        • Contact:
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
      • Waukesha, Wisconsin, United States, 53022
      • Waupaca, Wisconsin, United States, 54981
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care-Milwaukee West
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Osimertinib
Drug: 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.
Other Names:
  • Tagrisso
Group 2
Osimertinib + Chemotherapy
Drug: 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.
Other Names:
  • Tagrisso, Cisplatin, Carboplatin, Pemetrexed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
real-world Progression-Free Survival (rwPFS)
Time Frame: From initiation of therapy to progression or death, up to 3 years
Time from initiating therapy to progression or death without documented progression
From initiation of therapy to progression or death, up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
real-world Overall Survival (rwOS)
Time Frame: From initiation of therapy to death, up to 3 years
Time from initial therapy to death from any cause.
From initiation of therapy to death, up to 3 years
real-world time to treatment discontinuation (rwTTD)
Time Frame: From initiation of therapy to discontinuation of osimertinib, up to 3 years
Time from treatment initiation (osimertinib or osimertinib + chemotherapy) to discontinuation of osimertinib.
From initiation of therapy to discontinuation of osimertinib, up to 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes (PRO)
Time Frame: 3 years
Functional Assessment of Cancer Therapy-G7+1 Version 4 (FACT-G7+1)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PrECOG, LLC.

Collaborators

ECOG-ACRIN Cancer Research Group

Investigators

  • Study Chair: Suzanne Cole, MD, UT Southwestern Simmons Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PrE1702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is proprietary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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