Clinical trial NCT06245837: Treatment and Biomarker Testing Patterns,Treatment Outcomes in a/m NSCLC With and Without Actionable Genomic Alterations
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small-cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: To assess treatment patterns in advanced/metastatic NSCLC in Russia and its change over time.
timeFrame: 12 months
Secondary outcomes:
measure: To analyze demographic characteristics of patients with NSCLC treated in Russian oncology centers
timeFrame: 12 months
measure: To assess biomarker testing patterns in advanced/metastatic NSCLC
timeFrame: 12 months
measure: To analyze clinical characteristics of patients with NSCLC treated in Russian oncology centers
timeFrame: 12 months
Other outcomes:
measure: To describe patient tolerability issues associated with chemotherapy in second and subsequent lines of therapy
timeFrame: 12 months
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kostroma
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Kuzbass
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novokuznetsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
References: