NCT06245837Active, not recruitingNot Applicable
Multicenter, Non-interventional, Observational Study of Treatment and Biomarker Testing Patterns, Treatment Outcomes in Advanced/Metastatic NSCLC With and Without Actionable Genomic Alterations in Routine Clinical Practice in Russia
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- To assess treatment patterns in advanced/metastatic NSCLC in Russia and its change over time.
Study Overview
Brief Summary
Planned study population consists of approximately 1500 adult patients with a/m NSCLC in Russia, in about 20 oncological centers (in each center it is expected to recruit about 75 patients) in different regions of Russia in order to provide representative study sample
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Morphologically confirmed NSCLC with or without actionable genomic alterations (AGA, i.e. EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, RET, ERBB2 (HER2), or KRAS)
- •Age ≥18 years at the time of NSCLC diagnosis;
- •Locally advanced or metastatic disease defined as incident stage IIIB/IIIC/IV NSCLC or stage I-IIIA then progressed to stage IIIB-IV disease and not eligible for curative-intent treatment (the date of progression is included in the database);
- •Available data on at least one line of systemic therapy for advanced/metastatic disease within the period since January 2022 until January 2025;
- •Patients may be alive or deceased at the time of medical record abstraction
Exclusion Criteria
- •Patients participated or participating in clinical trials or any early access program within period since the index date until the end of study period;
- •Diagnosis of another cancer (except for melanoma/skin cancer) at or within 5 years prior to NSCLC diagnosis or any ongoing systemic anti-cancer therapy regimen at the time of NSCLC diagnosis
Outcomes
Primary Outcomes
To assess treatment patterns in advanced/metastatic NSCLC in Russia and its change over time.
Time Frame: 12 months
Treatment patterns after prescription of sequential/concurrent immunotherapy +/- platinum-based chemotherapy for non-AGA / AGA patients;
Secondary Outcomes
- To analyze clinical characteristics of patients with NSCLC treated in Russian oncology centers(12 months)
- To analyze demographic characteristics of patients with NSCLC treated in Russian oncology centers(12 months)
- To assess biomarker testing patterns in advanced/metastatic NSCLC(12 months)
Investigators
Study Sites (1)
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