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

NCT ID: NCT06245837

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-20

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Non-small-cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Arkhangelsk, , Russia

Site Status

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Barnaul, , Russia

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Irkutsk, , Russia

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Kemerovo, , Russia

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Kostroma, , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Novokuznetsk, , Russia

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Novosibirsk, , Russia

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Obninsk, , Russia

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Perm, , Russia

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Saint Petersburg, , Russia

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Ufa, , Russia

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Vladivostok, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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D133FR00204

Identifier Type: -

Identifier Source: org_study_id

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