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NCT Number: NCT06245837

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arkhangelsk, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. To analyze demographic characteristics of patients with NSCLC treated in Russian oncology centers

    Time frame: 12 months

    Mean age at the time of a/m NSCLC diagnosis;

  2. To assess biomarker testing patterns in advanced/metastatic NSCLC

    Time frame: 12 months

    PD-L1 expression status

  3. To analyze clinical characteristics of patients with NSCLC treated in Russian oncology centers

    Time frame: 12 months

    Proportion of patients with de novo and recurrent advanced/metastatic disease

Other outcomes

  1. To describe patient tolerability issues associated with chemotherapy in second and subsequent lines of therapy

    Time frame: 12 months

    Percentage of adverse events associated with chemotherapy in second and subsequent lines of therapy

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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