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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Non Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Walnut Creek

John Muir Health, Walnut Creek, California, United States, 94598

Englewood

Miami Valley Hospital North, Englewood, Ohio, United States, 45415

Fort Worth

JPS Oncology & Infusion Center, Fort Worth, Texas, United States, 76104

Janesville

Mercyhealth Hospital and Cancer Center - Janesville, Janesville, Wisconsin, United States, 53548

Waukesha

ProHealth, Waukesha, Wisconsin, United States, 53022

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Patient must not have received any prior treatment with an EGFR TKI agent. 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.
  • * Patient must not be participating in EA5182 or any other treatment trial. Osimertinib +/- chemotherapy must be given as first-line treatment and 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.
  • * Patient must have the ability to understand and willingness to sign IRB-approved consent for data collection and study-related analyses. This is not a treatment trial.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

PrECOG, LLC.,

Suzanne Cole, MD, STUDY_CHAIR, UT Southwestern Simmons Comprehensive Cancer Center

Study Record Dates

2029-08