Study Stopped
Cancelled due to changes in the scientific landscape. Decision was made after thorough evaluation of of pros\&cons, ethical as well as regulatory consideration
Observational Study of Patients With Locally Advanced or Metastatic NSCLC (Non-Small Cell Lung Cancer)
PANORAMA
Global PANORAMA Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With Locally Advanced or Metastatic NSCLC.
1 other identifier
observational
89
6 countries
110
Brief Summary
This is an observational cohort study of patients with locally advanced or metastatic NSCLC (non-small cell lung cancer). Patients will be recruited from participating sites in Europe, Asia, and Canada. The study will include 2 patient cohorts.
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 Mar 2017
Shorter than P25 for all trials
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2017
CompletedFebruary 8, 2018
February 1, 2018
8 months
February 7, 2017
February 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Parameters in the target population associate with molecular testing patters
* Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the cohorts * Changes in testing rates over time (details will be included in the SAP) * Molecular testing details including, but not limited to 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
Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months
Parameters in the target population associate with treatment patterns and associated clinical outcomes
* Overall survival measured from: * the date of initial diagnosis to date of death from any cause to the index date to date of death from any cause (for primary cohort only) * the date of first-line treatment until death * the date of second-line treatment until death * Overall disease progression: o from date of treatment initiation until physician-reported progression, initiation of a new cancer-directed line of therapy (proxy for progression), or death * For each line of chemotherapy/targeted therapy received: * Therapy regimen * Therapy duration measured as time from therapy start date to time of therapy end date * Number of cycles received * Reason for cessation of therapy * Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy * For each surgery or radiotherapy received: * Type * Site * Date * Any palliative/supportive care received
Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months
Secondary Outcomes (4)
Estimation of parameters in the target population associate with cancer-related health care utilization patters including inpatient, emergency room, outpatient visits, lenght of inpatient stay
Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months
Estimation of parameters in the target population associated with treatment- and biopsy-related complications
Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months
Estimation of the rate of CNS metastases in the target population including brain metastases and leptomeningeal metastases and treatments associated with CNS metastases
Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months
Assessment of patient (HRQoL) using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and EORTC QLQ - Lung Cancer 13 items (EORTC QLQ-LC13)3
Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months
Study Arms (2)
Patients with EGFR mutation (+) NSCLC
Patients with EGFR mutation-positive locally advanced or metastatic NSCLC who have progressed while on or after receiving front-line EGFR-TKI therapy (e.g., gefitinib, erlotinib, afatinib, or icotinib).
Patients newly diagnosed NSCLC
Patients newly diagnosed with locally advanced or metastatic NSCLC who are treatment naive or patients who were diagnosed at an earlier stage but have progressed to metastatic NSCLC during the selection period.
Interventions
HRQoL will be assessed using questionnaire EORTC QLQ-C30 and the questionnaire EORTC QLQ-LC 13. These two questionnaires are validated instruments, translated in various languages and are not used as an intervention but rather to track patient quality of life and symptom reduction in real-life settings. Data for these patient reported outcomes will be collected prospectively from the time of enrolment until the end of follow-up. The two questionnaires will be self-administered by the patients in both cohorts at the enrolment visit and subsequently every 3 months (±1 month) at routine standard of care scheduled visits. The questionnaires are expected to take about 15 minutes to complete
Eligibility Criteria
* Adult male or female patients (according to age of majority/adulthood as defined by local regulations) who have given written informed consent as per local regulations. * The primary cohort will include patients with EGFR mutation-positive locally advanced or metastatic NSCLC who have progressed while on or after receiving front-line EGFR-TKI therapy (e.g., gefitinib, erlotinib, afatinib, or icotinib). * Additionally, a secondary cohort of patients will include patients newly diagnosed with locally advanced or metastatic NSCLC who are treatment naive or patients who were diagnosed at an earlier stage but have progressed to metastatic NSCLC during the selection period. (In Spain and France the secondary cohort of patient will be limited to patients with EGFR mutation-positive locally advanced or metastatic NSCLC)
You may qualify if:
- Provision of written informed consent - patient consent should be within 6 weeks of index date.
- Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
You may not qualify if:
- Enrolment in studies that prohibit any participation in this non interventional study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (110)
Research Site
Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Newmarket, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Hefei, Anhui, China
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Harbin, Heilongjiang, China
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Shanghai, Shanghai Municipality, China
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Xian, Shanxi, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Aix-en-Provence, Bouches-du-Rhone, France
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Brest, Brittany Region, France
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Tours, Centre-Val de Loire, France
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Colmar, Haut-Rhin, France
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Rouen, Haute-Normandie, France
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Metz-Tessy, Haute-Savoie, France
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Limoges, Haute-Vienne, France
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Nantes, Loire-Atlantique, France
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Saint-Nazaire, Loire-Atlantique, France
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Angers, Maine-et-Loire, France
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Lorient, Morbihan, France
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Saint Priest En Jarez, Pays de la Loire Region, France
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Marseille, Provence-Alpes-Côte d'Azur Region, France
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Bayonne, Pyrenees-Atlantiques, France
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Villefranche-sur-Saône, Rhone, France
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Le Mans, Sarthe, France
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Créteil, Val-de-Marne, France
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Toulon, Var, France
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Brieuc Cedex 1, France
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Cannes, France
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Chambéry, France
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Clermont-Ferrand, France
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Gap, France
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La Réunion, France
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La Rochelle, France
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Libourne, France
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Mantes-la-Jolie, France
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Meaux, France
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Montfermeil, France
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Mulhouse, France
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Orléans, France
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Paris, France
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Poitiers, France
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Rennes, France
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Saint-Pierre, France
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Saint-Quentin, France
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Strasbourg, France
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Toulouse, France
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Troyes, France
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Suresnes, Île-de-France Region, France
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Seville, Andalusia, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Badalona, Barcelona, Spain
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Mataró, Barcelona, Spain
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Sabadell, Barcelona, Spain
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Jerez de la Frontera, Cadiz, Spain
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Las Palmas de Gran Canaria, Canary Islands, Spain
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A Coruña, Galicia, Spain
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Majadahonda, Madrid, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Oviedo, Principality of Asturias, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
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Reus, Tarragona, Spain
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Barcelona, Spain
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Burgos, Spain
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Granada, Spain
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Jaén, Spain
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Lugo, Spain
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Madrid, Spain
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Málaga, Spain
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Navarra, Spain
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Pontevedra, Spain
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Seville, Spain
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Zaragoza, Spain
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Taichung, Taichung Municipality, Taiwan
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Changhua, Taiwan
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Hsinchu, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Whitchurch, Cardiff, United Kingdom
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Hull, East Riding Of Yorkshire, United Kingdom
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Brighton, East Sussex, United Kingdom
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Maidstone, Kent, United Kingdom
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Metropolitan Borough of Wirral, Liverpool, United Kingdom
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Birmingham, United Kingdom
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Bristol, United Kingdom
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Camberley, United Kingdom
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Glasgow, United Kingdom
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Ipswich, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Nottingham, United Kingdom
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Scunthorpe, United Kingdom
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Sheffield, United Kingdom
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Wolverhampton, United Kingdom
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Worcester, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Danielle Potter, PhD, MPH
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2017
First Posted
February 15, 2017
Study Start
March 1, 2017
Primary Completion
November 8, 2017
Study Completion
November 8, 2017
Last Updated
February 8, 2018
Record last verified: 2018-02