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.

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Other: Patient Reported Outcomes

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.

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	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
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 deaththe 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 regimenTherapy duration measured as time from therapy start date to time of therapy end dateNumber of cycles receivedReason for cessation of therapyTime 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:TypeSiteDate; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 visitsTotal 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
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
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Danielle Potter, PhD, MPH, AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): November 8, 2017
• Study Completion (Actual): November 8, 2017

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC; Non-Small Cell Lung Cancer; Immunotherapy; EGFR; Osimertinib; Personalized medicine; Resistance; Carcinoma, Non-Small-Cell Lung; PRO; Observational study; Radiation; Bronchial Neoplasms; EGFR mutation; Patient Reported Outcome; Lung diseases; T790M; EGFR-TKI; Health-Related Quality of Life; Lung Neoplasms; Carcinoma, Bronchogenic; EGFRm; Respiratory Tract Neoplasms; Combination Chemotherapy; Health care resource utilization; Locally advanced or metastatic lung cancer; Thoracic neoplasms, Neoplasms by site; Respiratory Tract diseases; Cancer Chemotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma
• Other Study ID Numbers: D5160R00010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No