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

Non-small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245837
• Other study ID #: D133FR00204
• Status: Recruiting
• Start date: March 20, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small-cell Lung Cancer

Locations

Country	Name	City	State
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Khabarovsk
Russian Federation	Research Site	Kostroma
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Rostov-on-Don
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Surgut
Russian Federation	Research Site	Tula
Russian Federation	Research Site	Vladivostok
Russian Federation	Research Site	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To describe patient tolerability issues associated with chemotherapy in second and subsequent lines of therapy	Percentage of adverse events associated with chemotherapy in second and subsequent lines of therapy	12 months
Primary	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	To analyze demographic characteristics of patients with NSCLC treated in Russian oncology centers	Mean age at the time of a/m NSCLC diagnosis;	12 months
Secondary	To assess biomarker testing patterns in advanced/metastatic NSCLC	PD-L1 expression status	12 months
Secondary	To analyze clinical characteristics of patients with NSCLC treated in Russian oncology centers	Proportion of patients with de novo and recurrent advanced/metastatic disease	12 months