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

NCT ID: NCT02777658

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-26

Study Completion Date

2020-05-31

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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

• Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iOMEDICO AG, Freiburg, Germany

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Aschaffenburg, , Germany

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Augsburg, , Germany

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Bad Kreuznach, , Germany

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Ballenstedt, , Germany

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Bautzen, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Bonn, , Germany

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Bottrop, , Germany

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Bremen, , Germany

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Celle, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Erfurt, , Germany

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Esslingen am Neckar, , Germany

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Frankfurt (Oder), , Germany

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Freiburg i.Br., , Germany

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Freital, , Germany

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Fürth, , Germany

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Gauting, , Germany

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Georgsmarienhütte, , Germany

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Goslar, , Germany

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Göttingen, , Germany

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Greifenstein, , Germany

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Güstrow, , Germany

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Gütersloh, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heidenheim, , Germany

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Herne, , Germany

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Hildesheim, , Germany

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Hof, , Germany

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Kaiserslautern, , Germany

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Karlsruhe, , Germany

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Kempten, , Germany

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Koblenz, , Germany

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Krefeld, , Germany

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Landshut, , Germany

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Lebach, , Germany

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Leipzig, , Germany

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Löwenstein, , Germany

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Ludwigsburg, , Germany

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Mainz, , Germany

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Mönchengladbach, , Germany

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Muehlheim A.d. Ruhr, , Germany

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München, , Germany

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Münnerstadt, , Germany

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Naunhof, , Germany

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Neustadt a.R., , Germany

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Nuremberg, , Germany

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Offenburg, , Germany

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Oldenburg, , Germany

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Osnabrück, , Germany

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Pirna, , Germany

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Porta Westfalica, , Germany

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Ratingen, , Germany

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Ravensburg, , Germany

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Rosenheim, , Germany

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Rostock, , Germany

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Schorndorf, , Germany

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Stolberg, , Germany

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Stuttgart, , Germany

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Twistringen, , Germany

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Völklingen, , Germany

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Wangen, , Germany

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Westerstede, , Germany

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Wiesbaden, , Germany

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Witten, , Germany

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Würselen, , Germany

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Würzburg, , Germany

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Zittau, , Germany

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Countries

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Germany

Other Identifiers

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D5160R00005

Identifier Type: -

Identifier Source: org_study_id

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