PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC

Study Overview
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Brief Summary
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The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.

Official Title
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PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With EGFR Mutation-Positive Locally Advanced or Advanced NSCLC

Conditions
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Carcinoma, Non-Small-Cell Lung

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Primary Study Cohort Provision of written informed consent (patient consent should be within 6 weeks of disease progression, defined elsewhere as the Index Date) Adult male or female subjects (according to age of majority/adulthood as defined by local regulations) Patients with prior confirmed EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC - Patients who developed resistance to an EGFR-TKI due to any other phenotypic/histologic transformations (e.g., small-cell lung cancer, EMT) or other mutations (e.g., HER2, MET amplifications) at the index-date will be eligible for participation in this study as long as they have prior confirmed diagnosis of EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC Patients who have progressed on or after EGFR-TKI therapy (i.e., gefitinib, erlotinib or afatinib) within the patient selection period Inclusion Criteria - Secondary Study Cohort Provision of written informed consent (patient consent should be within 6 weeks of NSCLC diagnosis, defined elsewhere as the Index Date) Adult male or female subjects (according to age of majority/adulthood as defined by local regulations) Patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC during the patient selection period. The de-novo T790M mutation can be alone or in combination with other mutations (e.g., L858R and T790M). Exclusion Criteria - Primary and Secondary Study Cohorts • Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Study Cohort<br>Patients with prior confirmed EGFR mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (Epidermal Growth Factor Receptor - Tyrosine Kinase Inhibitor) therapy | |
| Secondary Study Cohort<br>Patients diagnosed with de-novo (wild-type) EGFR T790M mutation-positive (alone or in combination with other mutations) locally advanced or advanced NSCLC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate molecular testing patterns among patients with EGFR mutation-positive locally advanced or advanced NSCLC | Molecular testing patterns including: Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the primary study cohort (applicable to patients in the primary study cohort); Change in testing rates over time - testing rate over time will be described; Molecular testing details including sample type, method of biopsy, testing turnaround time, test type, reason for testing, testing laboratory type, reason for not performing a test; Molecular testing results including mutation status and type, test outcome, histologic/phenotypic transformation; | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months | 
| To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC | Treatment patterns and associated clinical outcomes including: Overall survival measured from: date of initial diagnosis to date of death from any cause (for primary and secondary cohorts), date of progression to date of death from any cause (for primary cohort only); Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy; Treatment(s) received post diagnosis and post progression including chemotherapy, radiation, surgery, targeted therapy, immunotherapy; Treatment sequence patterns, line(s) of therapy, treatment regimen(s), treatment duration, number of cycles; | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess health care utilization patterns | Health care utilization patterns will be presented by the following care settings: hospitalization and length of stay, emergency room and physician office visits | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months | 
| To assess treatment related complications | Assessment of treatment related complications observed with chemotherapy and targeted therapies among patients with NSCLC. | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months | 
| To assess biopsy related complications | Assessment of biopsy related complications for each documented biopsy procedure | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months | 
| To document rate of central nervous system (CNS) metastases |  | Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months | 
| Assessment of health-related quality of life (HRQoL) | Health related quality of life (HRQoL): Assessment of general cancer-associated and specific lung cancer associated parameters by use of standardized HRQoL questionnaires: European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire - Core 30 (EORTC QLQ-C30) European Organisation For Research And Treatment Of Cancer Quality Of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13) (adminstered to patients included in primary study cohort) | Date of first visit to last visit. HRQoL are collected every 6 months (plus or minus 1.5 months) up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidermal Growth Factor Receptor (EGFR), non-small cell lung cancer (NSCLC), EGFR T790M, EGFR Mutation-Positive Locally Advanced or Advanced NSCLC