Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Josh Knapp
205-962-6860
jpknapp@uabmc.edu

More Details

Status
Recruiting
Sponsor
PrECOG, LLC.

Study Contact

Karen Fitzpatrick, RN
215-439-2294
PrE1702@precogllc.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.