Treatment and Biomarker Testing Patterns,Treatment Outcomes in a/m NSCLC With and Without Actionable Genomic Alterations

Recruiting

• Conditions: Non-small-cell Lung Cancer

• Registration Number: NCT06245837
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-07
• Study Start: 2024-03-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. 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)
2. Age ≥18 years at the time of NSCLC diagnosis;
3. 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);
4. Available data on at least one line of systemic therapy for advanced/metastatic disease within the period since January 2022 until January 2025;
5. Patients may be alive or deceased at the time of medical record abstraction

Exclusion Criteria

1. Patients participated or participating in clinical trials or any early access program within period since the index date until the end of study period;
2. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess treatment patterns in advanced/metastatic NSCLC in Russia and its change over time.	12 months	Treatment patterns after prescription of sequential/concurrent immunotherapy +/- platinum-based chemotherapy for non-AGA / AGA patients;

Secondary Outcome Measures

Name	Time	Method
To analyze clinical characteristics of patients with NSCLC treated in Russian oncology centers	12 months	Proportion of patients with de novo and recurrent advanced/metastatic disease
To analyze demographic characteristics of patients with NSCLC treated in Russian oncology centers	12 months	Mean age at the time of a/m NSCLC diagnosis;
To assess biomarker testing patterns in advanced/metastatic NSCLC	12 months	PD-L1 expression status

Trial Locations

Locations (1)

Research Site; 🇷🇺 Yaroslavl, Russian Federation