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

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 growth factor receptor (egfr)-mutant non-small cell lung cancer (nsclc) to better understand the safety and effectiveness of these standard of care regimens.

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.

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.

Keywords: osimertinib cisplatin carboplatin pemetrexed egfr mutated