Clinical trial NCT03053297: Observational Study of Patients With Locally Advanced or Metastatic NSCLC (Non-Small Cell Lung Cancer)
Official title: Global PANORAMA Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With Locally Advanced or Metastatic NSCLC.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: EGFR
EGFR mutation
EGFRm
EGFR-TKI
Health care resource utilization
Health-Related Quality of Life
Locally advanced or metastatic lung cancer
NSCLC
Non-Small Cell Lung Cancer
Observational study
Osimertinib
Personalized medicine
PRO
Patient Reported Outcome
Resistance
T790M
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic neoplasms, Neoplasms by site
Lung diseases
Respiratory Tract diseases
Cancer Chemotherapy
Combination Chemotherapy
Immunotherapy
Radiation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-02-15
Enrollment: 89
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: * 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)

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.

Detailed description: Study Design This will be 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

-Enrolment in studies that prohibit any participation in this non interventional study

Primary outcomes:
measure: Parameters in the target population associate with molecular testing patters
timeFrame: 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
measure: Parameters in the target population associate with treatment patterns and associated clinical outcomes
timeFrame: 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:
measure: 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
timeFrame: 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
measure: Estimation of parameters in the target population associated with treatment- and biopsy-related complications
timeFrame: 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
measure: Estimation of the rate of CNS metastases in the target population including brain metastases and leptomeningeal metastases and treatments associated with CNS metastases
timeFrame: 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
measure: 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
timeFrame: 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
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: HaLifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Markham
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Harbin
country: China
facility: Research Site
state: Heilongjiang
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Xian
country: China
facility: Research Site
state: Shanxi
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Aix En Provence
country: France
facility: Research Site
state: Bouches-du-Rhone
city: Brest
country: France
facility: Research Site
state: Bretagne
city: Tours Cedex 9
country: France
facility: Research Site
state: Centre
city: Colmar
country: France
facility: Research Site
state: Haut-Rhin
city: Rouen
country: France
facility: Research Site
state: Haute-Normandie
city: Metz-Tessy
country: France
facility: Research Site
state: Haute-Savoie
city: Limoges
country: France
facility: Research Site
state: Haute-Vienne
city: Suresnes
country: France
facility: Research Site
state: Ile-de-France
city: Nantes Cedex 2
country: France
facility: Research Site
state: Loire-Atlantique
city: Saint Nazaire
country: France
facility: Research Site
state: Loire-Atlantique
city: Saint Priest En Jarez
country: France
facility: Research Site
state: Loire
city: Angers Cedex 9
country: France
facility: Research Site
state: Maine-et-Loire
city: Lorient
country: France
facility: Research Site
state: Morbihan
city: Marseille
country: France
facility: Research Site
state: Provence-Alpes-Cote-d'Azur
city: Bayonne
country: France
facility: Research Site
state: Pyrenees-Atlantiques
city: Villefranche-sur-Saone
country: France
facility: Research Site
state: Rhone
city: Le Mans cedex 9
country: France
facility: Research Site
state: Sarthe
city: Creteil
country: France
facility: Research Site
state: Val-de-Marne
city: Toulon
country: France
facility: Research Site
state: Var
city: Brieuc Cedex 1
country: France
facility: Research Site
city: Cannes CEDEX
country: France
facility: Research Site
city: Chambery
country: France
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Gap
country: France
facility: Research Site
city: La Reunion
country: France
facility: Research Site
city: La Rochelle Cedex
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Mantes la Jolie
country: France
facility: Research Site
city: Meaux
country: France
facility: Research Site
city: Montfermeil
country: France
facility: Research Site
city: Mulhouse
country: France
facility: Research Site
city: Orleans
country: France
facility: Research Site
city: Paris Cedex 14
country: France
facility: Research Site
city: Poitiers Cedex
country: France
facility: Research Site
city: Rennes, Cedex 9
country: France
facility: Research Site
city: Saint-Pierre
country: France
facility: Research Site
city: Saint-Quentin
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Troyes
country: France
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
state: Andalucia
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: Badalona
country: Spain
facility: Research Site
state: Barcelona
city: Mataro
country: Spain
facility: Research Site
state: Barcelona
city: Sabadell
country: Spain
facility: Research Site
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Research Site
state: Cadiz
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
state: Canarias
city: Coruna
country: Spain
facility: Research Site
state: Galicia
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Research Site
state: Madrid
city: San Cristobal de La Laguna
country: Spain
facility: Research Site
state: Santa Cruz De Tenerife
city: Reus
country: Spain
facility: Research Site
state: Tarragona
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Navarra
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
state: Taichung Municipality
city: Changhua
country: Taiwan
facility: Research Site
city: Hsinchu
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Whitchurch
country: United Kingdom
facility: Research Site
state: Cardiff
city: Hull
country: United Kingdom
facility: Research Site
state: East Riding Of Yorkshire
city: Brighton
country: United Kingdom
facility: Research Site
state: East Sussex
city: Maidstone
country: United Kingdom
facility: Research Site
state: Kent
city: Wirral
country: United Kingdom
facility: Research Site
state: Liverpool
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Camberley
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Ipswich
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Scunthorpe
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
city: Worcester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Danielle Potter, PhD, MPH
role: STUDY_DIRECTOR
References: