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Clinical Trials/NCT02777658
NCT02777658CompletedNot Applicable

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

AstraZeneca1 site in 1 country169 target enrollmentStarted: May 26, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
169
Locations
1
Primary Endpoint
To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • 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 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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