Observational Study of Patients With Locally Advanced or Metastatic NSCLC (Non-Small Cell Lung Cancer)

Carcinoma, Non-Small-Cell Lung Clinical Trial

— PANORAMA  

Official title:

Global PANORAMA Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With Locally Advanced or Metastatic NSCLC.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03053297
• Other study ID #: D5160R00010
• Status: Terminated
• Phase: N/A
• First received: February 7, 2017
• Last updated: February 6, 2018
• Start date: March 1, 2017
• Est. completion date: November 8, 2017

Study information

• Verified date: February 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: November 8, 2017
• Est. primary completion date: November 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Research Site	HaLifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Markham	Ontario
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Thunder Bay	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
China	Research Site	Beijing	Beijing
China	Research Site	Chengdu	Sichuan
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Harbin	Heilongjiang
China	Research Site	Hefei	Anhui
China	Research Site	Shanghai	Shanghai
China	Research Site	Xian	Shanxi
France	Research Site	Aix En Provence	Bouches-du-Rhone
France	Research Site	Angers Cedex 9	Maine-et-Loire
France	Research Site	Bayonne	Pyrenees-Atlantiques
France	Research Site	Brest	Bretagne
France	Research Site	Brieuc Cedex 1
France	Research Site	Cannes CEDEX
France	Research Site	Chambery
France	Research Site	Clermont Ferrand
France	Research Site	Colmar	Haut-Rhin
France	Research Site	Creteil	Val-de-Marne
France	Research Site	Gap
France	Research Site	La Reunion
France	Research Site	La Rochelle Cedex
France	Research Site	Le Mans cedex 9	Sarthe
France	Research Site	Libourne
France	Research Site	Limoges	Haute-Vienne
France	Research Site	Lorient	Morbihan
France	Research Site	Mantes la Jolie
France	Research Site	Marseille	Provence-Alpes-Cote-d'Azur
France	Research Site	Meaux
France	Research Site	Metz-Tessy	Haute-Savoie
France	Research Site	Montfermeil
France	Research Site	Mulhouse
France	Research Site	Nantes Cedex 2	Loire-Atlantique
France	Research Site	Orleans
France	Research Site	Paris Cedex 14
France	Research Site	Poitiers Cedex
France	Research Site	Rennes, Cedex 9
France	Research Site	Rouen	Haute-Normandie
France	Research Site	Saint Nazaire	Loire-Atlantique
France	Research Site	Saint Priest En Jarez	Loire
France	Research Site	Saint-Pierre
France	Research Site	Saint-Quentin
France	Research Site	Strasbourg
France	Research Site	Suresnes	Ile-de-France
France	Research Site	Toulon	Var
France	Research Site	Toulouse Cedex 9
France	Research Site	Tours Cedex 9	Centre
France	Research Site	Troyes
France	Research Site	Villefranche-sur-Saone	Rhone
Spain	Research Site	Badalona	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Burgos
Spain	Research Site	Coruna	Galicia
Spain	Research Site	Granada
Spain	Research Site	Jaen
Spain	Research Site	Jerez de la Frontera	Cadiz
Spain	Research Site	Las Palmas de Gran Canaria	Canarias
Spain	Research Site	Lugo
Spain	Research Site	Madrid
Spain	Research Site	Majadahonda	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Mataro	Barcelona
Spain	Research Site	Navarra
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Palma de Mallorca	Baleares
Spain	Research Site	Pontevedra
Spain	Research Site	Pozuelo de Alarcon	Madrid
Spain	Research Site	Reus	Tarragona
Spain	Research Site	Sabadell	Barcelona
Spain	Research Site	San Cristobal de La Laguna	Santa Cruz De Tenerife
Spain	Research Site	Sevilla
Spain	Research Site	Sevilla	Andalucia
Spain	Research Site	Zaragoza
Taiwan	Research Site	Changhua
Taiwan	Research Site	Hsinchu
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung	Taichung Municipality
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Brighton	East Sussex
United Kingdom	Research Site	Bristol
United Kingdom	Research Site	Camberley
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Hull	East Riding Of Yorkshire
United Kingdom	Research Site	Ipswich
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	London
United Kingdom	Research Site	Maidstone	Kent
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Newcastle Upon Tyne
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Scunthorpe
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Whitchurch	Cardiff
United Kingdom	Research Site	Wirral	Liverpool
United Kingdom	Research Site	Wolverhampton
United Kingdom	Research Site	Worcester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  China,  France,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	For each health care setting: Number and % of patients with visits; Total number of visits; Total length of inpatient hospital and ICU 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
Secondary	Estimation of parameters in the target population associated with treatment- and biopsy-related complications	For each treatment complication: o Rate of occurrence defined as the number of patients reporting at least one treatment-related complications divided by the number of evaluable patients2 Treatment-related complications can include, but are not limited to nausea and vomiting, diarrhoea, constipation, skin rash, infections, mouth sores, neutropenia, hyponatremia; For each biopsy-related complication: Rate of occurrence defined as the number of patients reporting at least one occurrence of the complication divided by the number of patients receiving a biopsy Biopsy-related complications can include but are not limited to collapsed lung, severe bleeding, bronchial spasms, irregular heart rhythms, death, severe chest pain, light-headedness, trouble breathing, excessive bleeding through the bandage, haemoptysis, fever, infection	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	Estimation of the rate of CNS metastases in the target population including brain metastases and leptomeningeal metastases and treatments associated with CNS metastases	Overall CNS metastases rate, defined as the number of patients developing CNS metastases divided by the number of evaluable patients; Brain metastases rate, defined as the number of patients developing brain metastases divided by the number of evaluable patients; Leptomeningeal metastases rate, defined as the number of patients developing leptomeningeal metastases divided by the number of evaluable patients; Treatments for CNS metastases, including type of treatment and dates of treatment	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	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	• Change in score from baseline for each Quality of Life (QoL) domain and for overall QoL, measured at each subsequent site visit	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