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

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT02777658
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Study Start: 2016-05-26
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC	Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months	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;
To evaluate molecular testing patterns among patients with EGFR mutation-positive locally advanced or advanced NSCLC	Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months	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;

Secondary Outcome Measures

Name	Time	Method
To assess treatment related complications	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 treatment related complications observed with chemotherapy and targeted therapies among patients with NSCLC.
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
To assess health care utilization patterns	Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months	Health care utilization patterns will be presented by the following care settings: hospitalization and length of stay, emergency room and physician office visits
To assess biopsy related complications	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 biopsy related complications for each documented biopsy procedure
Assessment of health-related quality of life (HRQoL)	Date of first visit to last visit. HRQoL are collected every 6 months (plus or minus 1.5 months) up to 36 months	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)

Trial Locations

Locations (1)

Research Site; 🇩🇪 Zittau, Germany