RECRUITING

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

Conditions

Non Small Cell Lung Cancer Epidermal Growth Factor Receptor Gene Mutation Stage III Lung Cancer Stage IV Lung Cancer Osimertinib Cisplatin Carboplatin Pemetrexed EGFR Mutated

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-17

Study Completion:2029-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06538038

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Alison Bricker, RN

CONTACT

609-845-8608

PrE1702@precogllc.org

Principal Investigator

Suzanne Cole, MD

STUDY_CHAIR

UT Southwestern Simmons Comprehensive Cancer Center

Study Locations (Sites)

John Muir Health

Walnut Creek, California, 94598

United States

Miami Valley Hospital North

Englewood, Ohio, 45415

United States

JPS Oncology & Infusion Center

Fort Worth, Texas, 76104

United States

Mercyhealth Hospital and Cancer Center - Janesville

Janesville, Wisconsin, 53548

United States

ProHealth

Waukesha, Wisconsin, 53022

United States

Collaborators and Investigators

Sponsor: PrECOG, LLC.

Suzanne Cole, MD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2024-09-17

Study Completion Date2029-08

Study Record Updates

Study Start Date2024-09-17

Study Completion Date2029-08

Terms related to this study

Keywords Provided by Researchers

Osimertinib
Cisplatin
Carboplatin
Pemetrexed
EGFR Mutated

Additional Relevant MeSH Terms

Non Small Cell Lung Cancer
Epidermal Growth Factor Receptor Gene Mutation
Stage III Lung Cancer
Stage IV Lung Cancer