Clinical trial NCT04742192: Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer
Official title: A Multicountry, Multicentre, Non-interventional, Prospective Study to Determine the Prevalence of EGFR Mutations in Patients With Early-stage, Surgically Resected, Non-squamous, Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who have stage IA to IIIB NSCLC with non-squamous histology and who have undergone surgical resection of tumour up to 6 weeks prior to enrolment

Brief summary: This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study.

The main objective of this study is to determine the prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB) non-squamous NSCLC as there are limited data on its prevalence in this patient population.

Detailed description: This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study. Eligible patients should have availability of formalin-fixed paraffin-embedded (FFPE) specimen(s) to be primarily tested for EGFRm at validated local laboratories or a central laboratory. The informed consent will be obtained from the patients during their routine clinical care visit before data are collected from the medical records. The data on socio-demographics, tumour staging, histology, surgical management, and neoadjuvant therapies will be collected from available medical records at the treating facility by the investigator. If PD-L1 testing is conducted as part of routine clinical care, the available results will be recorded. Patients will be followed prospectively and follow-up will be considered as complete once EGFRm status of the patient's tumour sample is known and any planned adjuvant therapy has been recorded.

Eligibility criteria: Inclusion Criteria:

* Adult male or female patients ≥18 years old or 'adults' according to age of majority as defined by the local regulations
* Patient or next of kin/legal representative is willing and able to provide informed consent according to the local regulations, where applicable
* Patients with stage IA to IIIB (on the basis of pathologic criteria) NSCLC with adenocarcinoma, or mixed histology with an adenocarcinoma component who have undergone surgical resection of the tumour during the preceding 6 weeks
* Availability of FFPE tissue specimen suitable for EGFRm testing (either the primary diagnostic sample or the surgically resected tumour specimen)
* Availability of medical records at the participating site detailing the initial diagnosis, staging, and surgical management of NSCLC

Exclusion Criteria:

Patients who fulfil any of the following exclusion criteria will not be eligible for the study:

1. Histology of the tumour is considered not to be of primary lung in origin
2. Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma differentiation -

Primary outcomes:
measure: Overall proportion of patients with EGFRm
timeFrame: 3 month
measure: Proportion of EGFRm in Pathologic Stage
timeFrame: 3 Month
Secondary outcomes:
measure: Proportion of patients with the EGFRm types
timeFrame: 3 Month
measure: Proportion of patients who were prescribed modalities
timeFrame: 3 Month
Other outcomes:
measure: Proportion of patients with a tumour PD-L1 IHC test result
timeFrame: 3 Month
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Rosario - Santa Fe
country: Argentina
facility: Research Site
city: Santiago de Chile
country: Chile
facility: Research Site
city: Santiago de Chile
country: Chile
facility: Research Site
city: Bogotá
country: Colombia
facility: Research Site
city: Montería -Cordoba
country: Colombia
facility: Research Site
city: San Jose
country: Costa Rica
facility: Research Site
city: Santo Domingo
country: Dominican Republic
facility: Research Site
city: Alexandria
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Tanta
country: Egypt
facility: Research Site
city: Kashmir
country: India
facility: Research Site
city: Kolkata
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: Cdmx
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Iliolo City
country: Philippines
facility: Research Site
city: Makati
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Taguig City
country: Philippines
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
References: