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

Sponsor

AbbVie (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06068842

Collaborator

(none)

500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Participants Undergoing Chart Review Participants treated for non small cell lung cancer undergoing chart review and retrospective mesenchymal epithelial transition (MET) overexpression (OE) testing of tissue biopsies.

Outcome Measures

Primary Outcome Measures

Presence of Mesenchymal Epithelial Transition (MET) protein overexpression (OE) [Up to 15 Months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.