PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC
PANORAMA
1 other identifier
observational
169
1 country
73
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2016
Longer than P75 for all trials
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedStudy Start
First participant enrolled
May 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedMay 27, 2021
May 1, 2021
4 years
May 17, 2016
May 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
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 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 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
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)
Date of first visit to last visit. HRQoL are collected every 6 months (plus or minus 1.5 months) up to 36 months
Study Arms (2)
Primary Study Cohort
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
Patients diagnosed with de-novo (wild-type) EGFR T790M mutation-positive (alone or in combination with other mutations) locally advanced or advanced NSCLC
Eligibility Criteria
800 patients across both cohorts - 700 patients primary cohort and 100 patients secondary cohort. Patients will be recruited from approximately 100 participating sites in Germany (70 hospitals and 30 outpatient practices).
You may qualify if:
- 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
- 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).
You may not qualify if:
- Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- iOMEDICO AG, Freiburg, Germanycollaborator
Study Sites (73)
Research Site
Aschaffenburg, D5160R00005, Germany
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Augsburg, D5160R00005, Germany
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Bad Kreuznach, D5160R00005, Germany
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Ballenstedt, D5160R00005, Germany
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Bautzen, D5160R00005, Germany
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Berlin, D5160R00005, Germany
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Bochum, D5160R00005, Germany
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Bonn, D5160R00005, Germany
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Bottrop, D5160R00005, Germany
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Bremen, D5160R00005, Germany
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Celle, D5160R00005, Germany
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Cologne, D5160R00005, Germany
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Dresden, D5160R00005, Germany
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Düsseldorf, D5160R00005, Germany
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Erfurt, D5160R00005, Germany
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Esslingen am Neckar, D5160R00005, Germany
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Frankfurt (Oder), D5160R00005, Germany
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Freiburg i.Br., D5160R00005, Germany
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Freital, D5160R00005, Germany
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Fürth, D5160R00005, Germany
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Gauting, D5160R00005, Germany
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Georgsmarienhütte, D5160R00005, Germany
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Goslar, D5160R00005, Germany
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Göttingen, D5160R00005, Germany
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Greifenstein, D5160R00005, Germany
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Güstrow, D5160R00005, Germany
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Gütersloh, D5160R00005, Germany
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Halle, D5160R00005, Germany
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Hamburg, D5160R00005, Germany
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Hanover, D5160R00005, Germany
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Heidenheim, D5160R00005, Germany
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Herne, D5160R00005, Germany
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Hildesheim, D5160R00005, Germany
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Hof, D5160R00005, Germany
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Kaiserslautern, D5160R00005, Germany
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Karlsruhe, D5160R00005, Germany
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Kempten, D5160R00005, Germany
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Koblenz, D5160R00005, Germany
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Krefeld, D5160R00005, Germany
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Landshut, D5160R00005, Germany
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Lebach, D5160R00005, Germany
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Leipzig, D5160R00005, Germany
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Löwenstein, D5160R00005, Germany
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Ludwigsburg, D5160R00005, Germany
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Mainz, D5160R00005, Germany
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Mönchengladbach, D5160R00005, Germany
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Muehlheim A.d. Ruhr, D5160R00005, Germany
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München, D5160R00005, Germany
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Münnerstadt, D5160R00005, Germany
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Naunhof, D5160R00005, Germany
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Neustadt a.R., D5160R00005, Germany
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Nuremberg, D5160R00005, Germany
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Offenburg, D5160R00005, Germany
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Oldenburg, D5160R00005, Germany
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Osnabrück, D5160R00005, Germany
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Pirna, D5160R00005, Germany
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Porta Westfalica, D5160R00005, Germany
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Ratingen, D5160R00005, Germany
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Ravensburg, D5160R00005, Germany
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Rosenheim, D5160R00005, Germany
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Rostock, D5160R00005, Germany
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Schorndorf, D5160R00005, Germany
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Stolberg, D5160R00005, Germany
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Stuttgart, D5160R00005, Germany
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Twistringen, D5160R00005, Germany
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Völklingen, D5160R00005, Germany
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Wangen, D5160R00005, Germany
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Westerstede, D5160R00005, Germany
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Wiesbaden, D5160R00005, Germany
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Witten, D5160R00005, Germany
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Würselen, D5160R00005, Germany
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Würzburg, D5160R00005, Germany
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Zittau, D5160R00005, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2016
First Posted
May 19, 2016
Study Start
May 26, 2016
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
May 27, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.