Trial Title:
Treatment and Biomarker Testing Patterns,Treatment Outcomes in a/m NSCLC With and Without Actionable Genomic Alterations
NCT ID:
NCT06245837
Condition:
Non-small-cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Arkhangelsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barnaul
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chelyabinsk
Country:
Russian Federation
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Kemerovo
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kostroma
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Krasnoyarsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kuzbass
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Novokuznetsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Novokuznetsk
Country:
Russian Federation
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Novosibirsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Obninsk
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Perm
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rostov-on-Don
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Saint-Petersburg
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tomsk
Country:
Russian Federation
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Ufa
Country:
Russian Federation
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vladivostok
Country:
Russian Federation
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Yaroslavl
Country:
Russian Federation
Status:
Recruiting
Start date:
March 20, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06245837
