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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06068842

Acronym

METRIX

Enrollment

579

Registered

2023-10-05

Start date

2023-11-03

Completion date

2024-12-31

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, Telisotuzumab Vedotin, ABBV-399, Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Argentina, Brazil, Canada, China, Israel, Japan, South Korea, Spain, Switzerland, Taiwan, United Arab Emirates, United Kingdom

Outcome results