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

Sponsor

AstraZeneca (Industry)

Overall Status

Terminated

CT.gov ID

NCT03053297

Collaborator

(none)

Enrollment

110

Locations

8.3

Actual Duration (Months)

0.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

89 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Nov 8, 2017

Actual Study Completion Date :

Nov 8, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Parameters in the target population associate with molecular testing patters [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]
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
Parameters in the target population associate with treatment patterns and associated clinical outcomes [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]
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

Secondary Outcome Measures

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]
For each health care setting: Number and % of patients with visits Total number of visits Total length of inpatient hospital and ICU stay
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]
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
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]
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
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]
• Change in score from baseline for each Quality of Life (QoL) domain and for overall QoL, measured at each subsequent site visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Winnipeg	Manitoba	Canada
2	Research Site	Moncton	New Brunswick	Canada
3	Research Site	HaLifax	Nova Scotia	Canada
4	Research Site	Hamilton	Ontario	Canada
5	Research Site	Kingston	Ontario	Canada
6	Research Site	London	Ontario	Canada
7	Research Site	Markham	Ontario	Canada
8	Research Site	Newmarket	Ontario	Canada
9	Research Site	Thunder Bay	Ontario	Canada
10	Research Site	Toronto	Ontario	Canada
11	Research Site	Montreal	Quebec	Canada
12	Research Site	Hefei	Anhui	China
13	Research Site	Beijing	Beijing	China
14	Research Site	Guangzhou	Guangdong	China
15	Research Site	Harbin	Heilongjiang	China
16	Research Site	Shanghai	Shanghai	China
17	Research Site	Xian	Shanxi	China
18	Research Site	Chengdu	Sichuan	China
19	Research Site	Hangzhou	Zhejiang	China
20	Research Site	Aix En Provence	Bouches-du-Rhone	France
21	Research Site	Brest	Bretagne	France
22	Research Site	Tours Cedex 9	Centre	France
23	Research Site	Colmar	Haut-Rhin	France
24	Research Site	Rouen	Haute-Normandie	France
25	Research Site	Metz-Tessy	Haute-Savoie	France
26	Research Site	Limoges	Haute-Vienne	France
27	Research Site	Suresnes	Ile-de-France	France
28	Research Site	Nantes Cedex 2	Loire-Atlantique	France
29	Research Site	Saint Nazaire	Loire-Atlantique	France
30	Research Site	Saint Priest En Jarez	Loire	France
31	Research Site	Angers Cedex 9	Maine-et-Loire	France
32	Research Site	Lorient	Morbihan	France
33	Research Site	Marseille	Provence-Alpes-Cote-d'Azur	France
34	Research Site	Bayonne	Pyrenees-Atlantiques	France
35	Research Site	Villefranche-sur-Saone	Rhone	France
36	Research Site	Le Mans cedex 9	Sarthe	France
37	Research Site	Creteil	Val-de-Marne	France
38	Research Site	Toulon	Var	France
39	Research Site	Brieuc Cedex 1		France
40	Research Site	Cannes CEDEX		France
41	Research Site	Chambery		France
42	Research Site	Clermont Ferrand		France
43	Research Site	Gap		France
44	Research Site	La Reunion		France
45	Research Site	La Rochelle Cedex		France
46	Research Site	Libourne		France
47	Research Site	Mantes la Jolie		France
48	Research Site	Meaux		France
49	Research Site	Montfermeil		France
50	Research Site	Mulhouse		France
51	Research Site	Orleans		France
52	Research Site	Paris Cedex 14		France
53	Research Site	Poitiers Cedex		France
54	Research Site	Rennes, Cedex 9		France
55	Research Site	Saint-Pierre		France
56	Research Site	Saint-Quentin		France
57	Research Site	Strasbourg		France
58	Research Site	Toulouse Cedex 9		France
59	Research Site	Troyes		France
60	Research Site	Sevilla	Andalucia	Spain
61	Research Site	Oviedo	Asturias	Spain
62	Research Site	Palma de Mallorca	Baleares	Spain
63	Research Site	Badalona	Barcelona	Spain
64	Research Site	Mataro	Barcelona	Spain
65	Research Site	Sabadell	Barcelona	Spain
66	Research Site	Jerez de la Frontera	Cadiz	Spain
67	Research Site	Las Palmas de Gran Canaria	Canarias	Spain
68	Research Site	Coruna	Galicia	Spain
69	Research Site	Majadahonda	Madrid	Spain
70	Research Site	Pozuelo de Alarcon	Madrid	Spain
71	Research Site	San Cristobal de La Laguna	Santa Cruz De Tenerife	Spain
72	Research Site	Reus	Tarragona	Spain
73	Research Site	Barcelona		Spain
74	Research Site	Burgos		Spain
75	Research Site	Granada		Spain
76	Research Site	Jaen		Spain
77	Research Site	Lugo		Spain
78	Research Site	Madrid		Spain
79	Research Site	Malaga		Spain
80	Research Site	Navarra		Spain
81	Research Site	Pontevedra		Spain
82	Research Site	Sevilla		Spain
83	Research Site	Zaragoza		Spain
84	Research Site	Taichung	Taichung Municipality	Taiwan
85	Research Site	Changhua		Taiwan
86	Research Site	Hsinchu		Taiwan
87	Research Site	Kaohsiung		Taiwan
88	Research Site	Taichung		Taiwan
89	Research Site	Tainan		Taiwan
90	Research Site	Taipei		Taiwan
91	Research Site	Taoyuan		Taiwan
92	Research Site	Whitchurch	Cardiff	United Kingdom
93	Research Site	Hull	East Riding Of Yorkshire	United Kingdom
94	Research Site	Brighton	East Sussex	United Kingdom
95	Research Site	Maidstone	Kent	United Kingdom
96	Research Site	Wirral	Liverpool	United Kingdom
97	Research Site	Birmingham		United Kingdom
98	Research Site	Bristol		United Kingdom
99	Research Site	Camberley		United Kingdom
100	Research Site	Glasgow		United Kingdom
101	Research Site	Ipswich		United Kingdom
102	Research Site	Leeds		United Kingdom
103	Research Site	London		United Kingdom
104	Research Site	Manchester		United Kingdom
105	Research Site	Newcastle Upon Tyne		United Kingdom
106	Research Site	Nottingham		United Kingdom
107	Research Site	Scunthorpe		United Kingdom
108	Research Site	Sheffield		United Kingdom
109	Research Site	Wolverhampton		United Kingdom
110	Research Site	Worcester		United Kingdom