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

Objective
Overall Objective:
-To develop an infrastructure to conduct a study comparing outcomes in patients with EGFR-mutated NSCLC treated with osimertinib +/- chemotherapy and not enrolled in a clinical trial.

Primary Objectives:
-To prospectively obtain key data elements (including exposures and covariates) and prospectively identify real-world outcomes relevant to non-randomized comparisons of treatment in patients with EGFR-mutated NSCLC in routine clinical care.
-Conduct a prospective non-interventional study to assess rwPFS and rwOS in a population of EGFR-mutated NSCLC patients treated with osimertinib +/- chemotherapy.

Secondary Objectives:
-Analyze the osimertinib and the osimertinib + chemotherapy groups for covariates associated with good/poor outcomes.
-Assess real-world time to treatment discontinuation (rwTTD) and OS.
-Model the difference in rwPFS of patients in this non-interventional study versus the PFS in patients randomized to the osimertinib arm of the EA5182 clinical trial including assessment of patient characteristics and potential confounders

Treatment 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.

Key Eligibility 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.

Applicable Disease Sites
Lung

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital