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Clinical Trials/NCT06245837
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

AstraZeneca1 site in 1 country1,500 target enrollmentStarted: March 20, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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