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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— PANORAMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777658
• Other study ID #: D5160R00005
• Status: Completed
• Start date: May 26, 2016
• Est. completion date: May 31, 2020

Study information

• Verified date: May 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Germany	Research Site	Aschaffenburg
Germany	Research Site	Augsburg
Germany	Research Site	Bad Kreuznach
Germany	Research Site	Ballenstedt
Germany	Research Site	Bautzen
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Bonn
Germany	Research Site	Bottrop
Germany	Research Site	Bremen
Germany	Research Site	Celle
Germany	Research Site	Dresden
Germany	Research Site	Duesseldorf
Germany	Research Site	Erfurt
Germany	Research Site	Esslingen
Germany	Research Site	Frankfurt-Oder
Germany	Research Site	Freiburg i.Br.
Germany	Research Site	Freital
Germany	Research Site	Fuerth
Germany	Research Site	Gauting
Germany	Research Site	Georgsmarienhuette
Germany	Research Site	Goettingen
Germany	Research Site	Goslar
Germany	Research Site	Greifenstein
Germany	Research Site	Guestrow
Germany	Research Site	Guetersloh
Germany	Research Site	Halle-Saale
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Heidenheim
Germany	Research Site	Herne
Germany	Research Site	Hildesheim
Germany	Research Site	Hof
Germany	Research Site	Kaiserslautern
Germany	Research Site	Karlsruhe
Germany	Research Site	Kempten
Germany	Research Site	Koblenz
Germany	Research Site	Koeln
Germany	Research Site	Krefeld
Germany	Research Site	Landshut
Germany	Research Site	Lebach
Germany	Research Site	Leipzig
Germany	Research Site	Loewenstein
Germany	Research Site	Ludwigsburg
Germany	Research Site	Mainz
Germany	Research Site	Moenchengladbach
Germany	Research Site	Muehlheim A.d. Ruhr
Germany	Research Site	Muenchen
Germany	Research Site	Muennerstadt
Germany	Research Site	Naunhof
Germany	Research Site	Neustadt a.R.
Germany	Research Site	Nuernberg
Germany	Research Site	Offenburg
Germany	Research Site	Oldenburg
Germany	Research Site	Osnabrueck
Germany	Research Site	Pirna
Germany	Research Site	Porta Westfalica
Germany	Research Site	Ratingen
Germany	Research Site	Ravensburg
Germany	Research Site	Rosenheim
Germany	Research Site	Rostock
Germany	Research Site	Schorndorf
Germany	Research Site	Stolberg
Germany	Research Site	Stuttgart
Germany	Research Site	Twistringen
Germany	Research Site	Voelklingen
Germany	Research Site	Wangen
Germany	Research Site	Westerstede
Germany	Research Site	Wiesbaden
Germany	Research Site	Witten
Germany	Research Site	Wuerselen
Germany	Research Site	Wuerzburg
Germany	Research Site	Zittau

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	iOMEDICO AG, Freiburg, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   Redacted CSR Synopsis