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
1 other identifier
observational
1,500
1 country
16
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2024
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedStudy Start
First participant enrolled
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
February 27, 2026
February 1, 2026
2.3 years
January 18, 2024
February 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To assess treatment patterns in advanced/metastatic NSCLC in Russia and its change over time.
Treatment patterns after prescription of sequential/concurrent immunotherapy +/- platinum-based chemotherapy for non-AGA / AGA patients;
12 months
Secondary Outcomes (3)
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
To analyze clinical characteristics of patients with NSCLC treated in Russian oncology centers
12 months
Other Outcomes (1)
To describe patient tolerability issues associated with chemotherapy in second and subsequent lines of therapy
12 months
Eligibility Criteria
Study population will consist of patients with a/m NSCLC with available data on at least one line of systemic therapy for advanced/metastatic disease within the period since January 2022 until January 2025.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (16)
Research Site
Arkhangelsk, Russia
Research Site
Barnaul, Russia
Research Site
Irkutsk, Russia
Research Site
Kemerovo, Russia
Research Site
Kostroma, Russia
Research Site
Krasnoyarsk, Russia
Research Site
Moscow, Russia
Research Site
Novokuznetsk, Russia
Research Site
Novosibirsk, Russia
Research Site
Obninsk, Russia
Research Site
Perm, Russia
Research Site
Saint Petersburg, Russia
Research Site
Ufa, Russia
Research Site
Vladivostok, Russia
Research Site
Yaroslavl, Russia
Research Site
Yekaterinburg, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2024
First Posted
February 7, 2024
Study Start
March 20, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.