A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants With Non-Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

— METRIX  

Official title:

International Real-World Study of MET Overexpression in Patients With Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068842
• Other study ID #: H24-281
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

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

External Links

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