Clinical trial NCT04808050: Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage Non-small Cell Lung Cancer
Official title: A Multicountry, Multicentre, Non-interventional, Retrospective Study to Determine the Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage (IA to IIIB) Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Resectable Early-stage (IA to IIIB)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with primary stage IA to IIIB NSCLC between 01 January 2013 and 31 December 2017 and followed up until at least 31 December 2020.

Brief summary: This is a non-interventional, multi-country, multicentre, retrospective study designed to determine the treatment patterns and associated survival rate in patients with primary stage IA to IIIB resectable NSCLC diagnosed between 01 January 2013 and 31 December 2017 and followed until at least 31 December 2020 The main objective of this study is to describe the treatment patterns and determine their associated 3-year survival rate according to clinical and pathologic staging in patients with resectable early-stage (IA to IIIB as per AJCC seventh edition) NSCLC.

Detailed description: This is a non-interventional, multi-country, multicentre, retrospective study designed to determine the treatment patterns and associated survival rate in patients with primary stage IA to IIIB resectable NSCLC diagnosed between 01 January 2013 and 31 December 2017 and followed until at least 31 December 2020. This study will also determine the prevalence of EGFR mutations and PD-L1 expression, and the clinical outcomes as per the treatment patterns and clinico-pathological staging. Data will be collected retrospectively from the patients' medical records from the date of initial diagnosis of early-stage NSCLC (index date) to the end of follow up ie, until death, the last medical record entry, or date of data extraction, whichever is the earliest. The data on treatment modalities, sociodemographic, clinico-pathological characteristics, and exposure and outcome variables (ie, medical and treatment history, disease staging, biomarker assessments, radiological findings, concomitant medications, survival), factor(s) for prescribing neo-adjuvant and/or adjuvant treatment and reason(s) for discontinuation will be extracted from patients' medical records.

Eligibility criteria: Inclusion Criteria:

1. Adult female and male patients aged ≥18 years or 'adults' according to age of majority as defined by the local regulations on index date
2. Patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver is granted) willing and able to provide written or electronic informed consent according to the local regulations, where applicable
3. Patients diagnosed with primary stage IA to IIIB NSCLC as per seventh edition AJCC whose tumour was deemed resectable between 01 January 2013 and 31 December 2017 and followed up until at least 31 December 2020, as per the medical records with availability of at least 12 months of follow-up data from the index date (date of diagnosis of early-stage \[IA to stage IIIB\] resectable NSCLC), unless patient died within 12 months of diagnosis.

Exclusion Criteria:

1. Patients with a concomitant cancer at the time of diagnosis of NSCLC, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of NSCLC diagnosis
2. Patients diagnosed with stage IV NSCLC
3. Histology of the tumour is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.

Primary outcomes:
measure: Proportion of patients per treatment modalities
timeFrame: 3 Years
measure: Duration of treatment
timeFrame: 3 years
measure: Survival rate
timeFrame: 3 Years
Secondary outcomes:
measure: Demographic characteristics
timeFrame: 3 Years
measure: Eastern Cooperative Oncology performance status Group characteristics
timeFrame: 3 Years
measure: Histological type
timeFrame: 3 Yewars
measure: Clinical-pathological Tumor stage
timeFrame: 3 Years
measure: TNM staging at index diagnosis
timeFrame: 1 Month
measure: Genetic alterations
timeFrame: 3 Years
measure: Survival rates at pre-defined landmark timepoints (other than 3-year)
timeFrame: 1 Years
measure: Prevalence of EGFR mutations
timeFrame: 3 Years
measure: Prevalence of PD-L1 expression
timeFrame: 3 Years
Other outcomes:
measure: Effectiveness outcomes rwDFS defined as time from the date of surgery to recurrence or death
timeFrame: 3 Years
measure: Effectiveness outcomes rwEFS rate at predefined landmark timepoints
timeFrame: 3 Years
measure: Effectiveness outcomes rwPFS defined as time from local or distant relapse to disease progression or death
timeFrame: 3 Years
Locations:
city: Sydney
country: Australia
facility: Research Site
state: New South Wales
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Perth
country: Australia
facility: Research Site
state: Western Australia
city: Alexandria
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Sohag
country: Egypt
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Faridabad
country: India
facility: Research Site
city: Howrah, Kolkata
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Kuwait City
country: Kuwait
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Diyarbakir
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Alain
country: United Arab Emirates
facility: Research Site
Study officials:
References: