Observational Study of Patients With Locally Advanced or Metastatic NSCLC (Non-Small Cell Lung Cancer)
NCT ID: NCT03053297
Last Updated: 2018-02-08
Study Results
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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TERMINATED
89 participants
OBSERVATIONAL
2017-03-01
2017-11-08
Brief Summary
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Patients will be recruited from participating sites in Europe, Asia, and Canada. The study will include 2 patient cohorts.
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Detailed Description
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Patients will be recruited from participating sites in Europe, Asia, and Canada. Patients meeting the study inclusion/exclusion criteria will be selected during a 24-month enrolment period per country and will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date (whichever occurs earlier). Data Sources Data will be collected following enrolment in the study and entered in the electronic case report form (eCRF). All data will be collected using patient medical records. The investigator will be responsible for ensuring that all the required data is collected and entered into the eCRF. The site will collect the patient questionnaires and the data will be uploaded according to the data entry procedures.
Study Population
* 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 (epidermal growth factor receptor) mutation-positive locally advanced or metastatic NSCLC who have progressed while on or after receiving front-line EGFR-TKI (tyrosine kinase inhibitors) 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.
Exposures There are no specific drug exposures or interventions being evaluated, as cohort eligibility (for both cohorts) is not exposure-based, but rather disease-based. All molecular testing and treatments will be at the discretion of the treating physician. Study Measures and Outcomes
* Patient demographic and clinical characteristics
* Molecular testing patterns and outcomes
* Treatment patterns
* Physician-reported clinical outcomes
* Cancer-related health care utilization
* Treatment- and biopsy-related complications
* CNS metastases (brain metastases and leptomeningeal metastases) and treatments associated with CNS (central nervous system) metastases
* HRQoL (Health Related Quality of Life) and symptoms Precision and Sample Size Estimations For the primary cohort the minimum sample size recommended for conducting a country-level analysis is 200 patients per country. This is based on the precision estimation calculation for the categorical study measure (% of patients tested) and will allow a maximum of
* 8.3% precision (i.e., assuming 50% undergoing molecular testing) around the point estimate for the categorical measure. For the secondary cohort the minimum sample size recommended for conducting a country-level analysis is 300 patients which was determined using precision estimates calculated for a categorical (% of patients tested) and a time-to-event (overall survival) measure. The overall study will include approximately 2800-3300 patients across all participating countries across both primary (1200-1300 patients) and secondary (1600-2000 patients) cohorts. Statistical Analysis No formal hypothesis testing is specified. Study measures including patient demographics and clinical characteristics, molecular testing patterns, treatment sequence patterns, physician-reported outcomes (overall survival) and patient-reported outcomes (HRQoL) will be reported by primary and secondary cohorts, unless indicated otherwise. Continuous study measures (e.g., age, duration of therapy) will be reported descriptively with mean, standard deviation, median, minimum and maximum. Frequencies and percentages will be used to document categorical measures of interest (e.g., number and proportion of patients with a post progression molecular test, number and proportion of patients with a T790M mutation) and will include 95% CIs for key outcome variables. Kaplan-Meier curves and median survival will be estimated, overall and on an exploratory basis by clinical and treatment characteristics of interest (provided there are sufficient events available; e.g., chemotherapy vs. targeted therapy) as pre-specified in the statistical analysis plan.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
Patient Reported Outcomes
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
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.
Patient Reported Outcomes
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
Interventions
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Patient Reported Outcomes
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
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Inclusion Criteria
* Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Danielle Potter, PhD, MPH
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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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 City, , 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
Countries
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Other Identifiers
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D5160R00010
Identifier Type: -
Identifier Source: org_study_id
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