Status:
RECRUITING
Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients
Lead Sponsor:
PrECOG, LLC.
Collaborating Sponsors:
ECOG-ACRIN Cancer Research Group
Conditions:
Non Small Cell Lung Cancer
Epidermal Growth Factor Receptor Gene Mutation
Eligibility:
All Genders
18+ years
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 Grow...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT06538038
Start Date
September 17 2024
End Date
August 1 2029
Last Update
December 22 2025
Active Locations (138)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mercy Clinic Fort Smith Communities
Fort Smith, Arkansas, United States, 72903
3
Mercy Research
Fort Smith, Arkansas, United States, 72903
4
Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States, 72401