Clinical trial NCT06538038: Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
Official title: Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Epidermal Growth Factor Receptor Gene Mutation
Stage III Lung Cancer
Stage IV Lung Cancer
Keywords: Osimertinib
Cisplatin
Carboplatin
Pemetrexed
EGFR Mutated
Lead sponsor: PrECOG, LLC.
Sponsor class: OTHER
Collaborators: name: ECOG-ACRIN Cancer Research Group
First posted: 2024-08-05
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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: 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.

Primary outcomes:
measure: real-world Progression-Free Survival (rwPFS)
timeFrame: From initiation of therapy to progression or death, up to 3 years
Secondary outcomes:
measure: real-world Overall Survival (rwOS)
timeFrame: From initiation of therapy to death, up to 3 years
measure: real-world time to treatment discontinuation (rwTTD)
timeFrame: From initiation of therapy to discontinuation of osimertinib, up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fort Smith
country: United States
facility: Mercy Clinic Fort Smith Communities
state: Arkansas
city: Fort Smith
country: United States
facility: Mercy Research
state: Arkansas
city: Jonesboro
country: United States
facility: Fowler Family Cancer Center - Jonesboro
state: Arkansas
city: Walnut Creek
country: United States
facility: John Muir Health
state: California
city: Dover
country: United States
facility: Bayhealth
state: Delaware
city: Milford
country: United States
facility: Satellite of Bayhealth Sussex
state: Delaware
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Hektoen Institute on Behalf of Stroger Hospital of Cook County Minority Underserved NCORP
state: Illinois
city: Urbana
country: United States
facility: Carle Founation Hospital
state: Illinois
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Burnsville
country: United States
facility: Minnesota Oncology - Burnsville
state: Minnesota
city: Cambridge
country: United States
facility: Cambridge Medical Center
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Maple Grove
country: United States
facility: Fairview Clinics and Surgery Center Maple Grove
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA-Maplewood
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Inc.
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: New Ulm
country: United States
facility: New Ulm Medical Center
state: Minnesota
city: Princeton
country: United States
facility: Fairview Northland Medical Center
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Medical Health Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro MN
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Shakopee
country: United States
facility: Saint Francis Regional Medical Center
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Waconia
country: United States
facility: Ridgeview Medical Center
state: Minnesota
city: Willmar
country: United States
facility: Rice Memorial Hospital
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology PA-Woodbury
state: Minnesota
city: Wyoming
country: United States
facility: Fairview Lakes Medical Center
state: Minnesota
city: Columbus
country: United States
facility: Baptist Memorial Hospital and Cancer Center - Golden Triangle
state: Mississippi
city: Grenada
country: United States
facility: Baptist Cancer Center - Grenada
state: Mississippi
city: Jackson
country: United States
facility: Jackson Oncology Associates PLLC
state: Mississippi
city: Jackson
country: United States
facility: Mississippi Baptist Medical Center
state: Mississippi
city: New Albany
country: United States
facility: Baptist Memorial Hospital and Cancer Center - Union
state: Mississippi
city: Oxford
country: United States
facility: Baptist Memorial Hospital and Cancer Center - Oxford
state: Mississippi
city: Southhaven
country: United States
facility: Baptist Memorial Hospital and Cancer Center - Desoto
state: Mississippi
city: Joplin
country: United States
facility: Mercy Clinic Joplin, LLC
state: Missouri
city: Rolla
country: United States
facility: Mercy Clinic Cancer and Hematology
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Clinic East Communities
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Clinic East Communities
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Springfield Communities
state: Missouri
city: Moorestown
country: United States
facility: Virtua Samson Cancer Center
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health Cancer Consortium Community Oncology Research Program
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital - Luckow Pavilion
state: New Jersey
city: Voorhees
country: United States
facility: Virtua Voorhees
state: New Jersey
city: New York
country: United States
facility: Montefiore
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Canton
country: United States
facility: Aultman
state: Ohio
city: Englewood
country: United States
facility: Miami Valley Hospital North
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Clinic Oklahoma Communities, Inc.
state: Oklahoma
city: Paoli
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Collierville
country: United States
facility: Baptist Memorial Hospital and Cancer Center - Collierville
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital and Cancer Center - Memphis
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital for Women
state: Tennessee
city: Dallas
country: United States
facility: UT Southwest
state: Texas
city: Fort Worth
country: United States
facility: JPS Oncology & Infusion Center
state: Texas
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Appleton
country: United States
facility: ThedaCare Regional Medical Center - Appleton
state: Wisconsin
city: Berlin
country: United States
facility: ThedaCare Cancer Care - Berlin
state: Wisconsin
city: Janesville
country: United States
facility: Mercyhealth Hospital and Cancer Center - Janesville
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Foundation
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora NCORP
state: Wisconsin
city: Neenah
country: United States
facility: ThedaCare Regional Medical Center - Neenah
state: Wisconsin
city: New London
country: United States
facility: ThedaCare Cancer Care - New London
state: Wisconsin
city: Oshkosh
country: United States
facility: ThedaCare Cancer Care - Oshkosh
state: Wisconsin
city: Shawano
country: United States
facility: ThedaCare Cancer Care - Shawano
state: Wisconsin
city: Waukesha
country: United States
facility: ProHealth
state: Wisconsin
city: Waupaca
country: United States
facility: ThedaCare Cancer Care - Waupaca
state: Wisconsin
Study officials:
affiliation: UT Southwestern Simmons Comprehensive Cancer Center
name: Suzanne Cole, MD
role: STUDY_CHAIR
References: