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

Active Not RecruitingN/A

Sponsor: PrECOG, LLC.

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

Interventions: Osimertinib, Osimertinib + Chemotherapy

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (146)

Birmingham, Alabama, United States
Fort Smith, Arkansas, United States
Fort Smith, Arkansas, United States
Jonesboro, Arkansas, United States
Emeryville, California, United States
Palo Alto, California, United States
San Jose, California, United States
Walnut Creek, California, United States
Dover, Delaware, United States
Milford, Delaware, United States
Washington D.C., District of Columbia, United States
Hinesville, Georgia, United States
Jesup, Georgia, United States
Savannah, Georgia, United States
Barrington, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
DeKalb, Illinois, United States
Geneva, Illinois, United States
Glenview, Illinois, United States
Grayslake, Illinois, United States
Hazel Crest, Illinois, United States
Lake Forest, Illinois, United States
Normal, Illinois, United States
Oak Lawn, Illinois, United States
Orland Park, Illinois, United States
Park Ridge, Illinois, United States
Urbana, Illinois, United States
Warrenville, Illinois, United States
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