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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06245837

Enrollment

1500

Registered

2024-02-07

Start date

2024-03-20

Completion date

2026-06-30

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell Lung Cancer

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

Russia

Outcome results