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OpenTrials
Completed

NCT Number: NCT06068842

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

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Italiano de Buenos Aires /ID# 256999, Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Presence of Mesenchymal Epithelial Transition (MET) protein overexpression (OE)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: METRIX

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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