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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06068842
Other study ID # H24-281
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 3, 2023
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source AbbVie
Contact Carlos Hader
Phone 844-663-3742
Email carlos.hader@abbvie.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases of which 60% are non-squamous (NSQ). This study will evaluate the prevalence of mesenchymal epithelial transition (MET) overexpression (OE) in adult participants with advanced or metastatic NSQ NSCLC. Archived tissue biopsies will be tested for MET OE and data from approximately 500 participants will be collected. No participants will be enrolled in this study. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 15 months. There is no additional burden for participants in this trial.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Previously consented and/or prospective collection of consent for research use of banked biological materials and clinical data. - Confirmed advanced and/or metastatic non-squamous (NSQ) non-small cell lung cancer (NSCLC). - Has formalin-fixed paraffin-embedded (FFPE) tissue collected since 2019. Exclusion Criteria: - Specimens collected before 2019. - Insufficient specimen tissue for testing. - Insufficient specimen quality (e.g., not 4-5 µm in thickness) which precludes testing. - Adenosquamous and sarcomatous histologies of NSCLC.

Study Design


Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires /ID# 256999 Ciudad Autonoma Buenos Aires Ciudad Autonoma De Buenos Aires
Argentina Instituto Alexander Fleming /ID# 256295 Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires
Canada Nova Scotia Health Authority /ID# 256950 Halifax Nova Scotia
Canada Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 257872 Québec Quebec
Canada Royal University Hospital /ID# 261272 Saskatoon Saskatchewan
Japan National Cancer Center Hospital /ID# 257889 Chuo-ku Tokyo
Switzerland Universitätsspital Basel /ID# 256677 Basel Town Basel-Stadt
United Kingdom Queen's University Belfast /ID# 258458 Belfast Northern Ireland
United Kingdom University Hospitals Birmingham NHS Foundation Trust /ID# 260991 Birmingham

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

Argentina,  Canada,  Japan,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of Mesenchymal Epithelial Transition (MET) protein overexpression (OE) OE is defined as: positive: >= 25% of tumor cells with 3+ staining intensity, or negative: < 25% of tumor cells with 3+ staining intensity. High overexpression (OE high) is defined as: positive: >= 50% of tumor cells with 3+ staining intensity negative: < 50% of tumor cells with 3+ staining intensity. These are determined by an immunohistochemistry (IHC) performed by the local laboratory. Up to 15 Months
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