Characterization of the Population, Treatment Patterns and Outcomes of Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm) - Multicenter Retrospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 250
- Primary Endpoint
- Sociodemographic Characteristics: Weight
Study Overview
Brief Summary
This study aims to better understand people who have advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation. NSCLC is an advanced stage cancer of the lung, occurring due to mutations (changes) in the EGFR gene. The study will assess the participant demographic background (that is age, gender etc.), the treatments they receive, how well those treatments work, and their health outcomes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed diagnosis of advanced or metastatic unresectable non-small cell lung cancerNSCLC (TNM stages IIIB-IV), and a documented EGFR mutation, between 01 July 2018 and 31 March 2022
- •Diagnosed and treated at one of the participating study centers within the defined study period
Exclusion Criteria
- •Participants who received any systemic cancer treatment outside the participating treatment centers
- •Participants diagnosed with any other malignancy within the 5 years prior to or during the study period, with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma
- •Participants enrolled in clinical trials during the study period.
Arms & Interventions
Unresectable Epidermal Growth Factor Receptor Mutated (EGFRm) NSCLC
Participants with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC), unresectable stage IIIB/C or IV at diagnosis, and a documented EGFR mutation will be included in this cohort. The existing secondary data from electronic health records (EHR) of these participants from approximately five selected Portuguese healthcare sites will be processed. Each participant will be followed up from index date (date on which participant is included in study) up to 31 March 2026 or at censoring, No intervention will be provided as a part of this study.
Outcomes
Primary Outcomes
Sociodemographic Characteristics: Weight
Time Frame: Baseline
Weight (in kilograms \[kg\]) of the participants will be reported.
Sociodemographic Characteristics: Age
Time Frame: Baseline
Age in years of the participants will be reported.
Sociodemographic Characteristics: Sex
Time Frame: Baseline
Sex (male, female) of the participants will be reported.
Sociodemographic Characteristics: Smoking Status
Time Frame: Baseline
Participants smoking status that is current or former smoker will be reported.
Sociodemographic Characteristics: Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame: Baseline
ECOG performance status of the participants will be reported.
Sociodemographic Characteristics: Disease Histopathology
Time Frame: Baseline
Number of participants based on disease histopathology will be reported.
Sociodemographic Characteristics: Type of Mutation
Time Frame: Baseline
Number of participants based on type of mutation will be reported.
Sociodemographic Characteristics: Disease Stage
Time Frame: Baseline
Number of participants based on the stage of disease will be reported.
Sociodemographic Characteristics: Cancer Metastasis
Time Frame: Baseline
Number of participants based on cancer metastasis will be reported.
EGFR Mutation Prevalence
Time Frame: Up to approximately 7 years 9 months
Number of participants with EGFR mutations will be reported.
Percentage of Participants by Type of Mutation of EGFR
Time Frame: Up to approximately 7 years 9 months
Percentage of participants by type of mutation of EGFR will be reported.
Secondary Outcomes
- Frequency of EGFR Mutations(Up to approximately 7 years 9 months)
- Number of Participants by Treatment Options(Up to approximately 7 years 9 months)
- Real-World Overall Survival (RW-OS)(Up to approximately 7 years 9 months)
- Real-World Progression-Free Survival (RW-PFS)(Up to approximately 7 years 9 months)
- RW-PFS from First Line of Treatment (RW-PFS 2)(Up to approximately 7 years 9 months)
- Real-World Time on Treatment (RW-TOT)(Up to approximately 7 years 9 months)
- Real-World Time to Next Treatment (RW-TTNT)(Up to approximately 7 years 9 months)
- Real-World Overall Response Rate (RW-ORR)(Up to approximately 7 years 9 months)
- Number of Appointments(Up to approximately 7 years 9 months)
- Number of Participants Receiving Complementary Diagnostic and Therapeutic Procedures(Up to approximately 7 years 9 months)
- Number Participants with Emergency Room Visits Related to NSCLC(Up to approximately 7 years 9 months)
- Percentage of Participants Hospitalized(Up to approximately 7 years 9 months)
- Number of Hospitalizations(Up to approximately 7 years 9 months)
- Median Length of Stay(Up to approximately 7 years 9 months)
- Net Costing(Up to approximately 7 years 9 months)