Clinical trial NCT02777658: PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC
Official title: PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With EGFR Mutation-Positive Locally Advanced or Advanced NSCLC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Epidermal Growth Factor Receptor (EGFR), non-small cell lung cancer (NSCLC), EGFR T790M, EGFR Mutation-Positive Locally Advanced or Advanced NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: iOMEDICO AG, Freiburg, Germany
First posted: 2016-05-19
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate molecular testing patterns among patients with EGFR mutation-positive locally advanced or advanced NSCLC
timeFrame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
measure: To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC
timeFrame: 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:
measure: To assess health care utilization patterns
timeFrame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
measure: To assess treatment related complications
timeFrame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
measure: To assess biopsy related complications
timeFrame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
measure: To document rate of central nervous system (CNS) metastases
timeFrame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
measure: Assessment of health-related quality of life (HRQoL)
timeFrame: Date of first visit to last visit. HRQoL are collected every 6 months (plus or minus 1.5 months) up to 36 months
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Kreuznach
country: Germany
facility: Research Site
city: Ballenstedt
country: Germany
facility: Research Site
city: Bautzen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Bottrop
country: Germany
facility: Research Site
city: Bremen
country: Germany
facility: Research Site
city: Celle
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Duesseldorf
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Esslingen
country: Germany
facility: Research Site
city: Frankfurt-Oder
country: Germany
facility: Research Site
city: Freiburg i.Br.
country: Germany
facility: Research Site
city: Freital
country: Germany
facility: Research Site
city: Fuerth
country: Germany
facility: Research Site
city: Gauting
country: Germany
facility: Research Site
city: Georgsmarienhuette
country: Germany
facility: Research Site
city: Goettingen
country: Germany
facility: Research Site
city: Goslar
country: Germany
facility: Research Site
city: Greifenstein
country: Germany
facility: Research Site
city: Guestrow
country: Germany
facility: Research Site
city: Guetersloh
country: Germany
facility: Research Site
city: Halle-Saale
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidenheim
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Hof
country: Germany
facility: Research Site
city: Kaiserslautern
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kempten
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Koeln
country: Germany
facility: Research Site
city: Krefeld
country: Germany
facility: Research Site
city: Landshut
country: Germany
facility: Research Site
city: Lebach
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Loewenstein
country: Germany
facility: Research Site
city: Ludwigsburg
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Moenchengladbach
country: Germany
facility: Research Site
city: Muehlheim A.d. Ruhr
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Muennerstadt
country: Germany
facility: Research Site
city: Naunhof
country: Germany
facility: Research Site
city: Neustadt a.R.
country: Germany
facility: Research Site
city: Nuernberg
country: Germany
facility: Research Site
city: Offenburg
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Osnabrueck
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Porta Westfalica
country: Germany
facility: Research Site
city: Ratingen
country: Germany
facility: Research Site
city: Ravensburg
country: Germany
facility: Research Site
city: Rosenheim
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Schorndorf
country: Germany
facility: Research Site
city: Stolberg
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Twistringen
country: Germany
facility: Research Site
city: Voelklingen
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Westerstede
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Wuerselen
country: Germany
facility: Research Site
city: Wuerzburg
country: Germany
facility: Research Site
city: Zittau
country: Germany
facility: Research Site
Study officials:
References: