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

January 27, 2025 updated by: AbbVie

International Real-World Study of MET Overexpression in Patients 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

579

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Ciudad Autonoma De Buenos Aires
      • Ciudad Autonoma Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires /ID# 256999
      • Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina, 1426
        • Instituto Alexander Fleming /ID# 256295
  • Brazil
      • Sao Paulo, Brazil, 01323-020
        • Hospital Alemao Oswaldo Cruz /ID# 256486
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 256487
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V8
        • Nova Scotia Health Authority /ID# 256950
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 257872
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital /ID# 261272
  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University /ID# 256906
  • Israel
    • H_efa
      • Haifa, H_efa, Israel, 3109601
        • Rambam Health Care Campus /ID# 256546
  • Japan
    • Osaka
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital /ID# 257890
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 257889
  • Korea, Republic of
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07345
        • The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 261511
  • Spain
      • Barcelona, Spain, 08017
        • UOMi Cancer Center - Clinica Tres Torres /ID# 261212
  • Switzerland
    • Basel-Stadt
      • Basel Town, Basel-Stadt, Switzerland, 4031
        • Universitätsspital Basel /ID# 256677
    • Zuerich
      • Zurich, Zuerich, Switzerland, 8006
        • University Hospital Zurich /ID# 256678
  • Taiwan
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 261542
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Burjeel Medical City /ID# 259407
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust /ID# 260991
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AE
        • Queen's University Belfast /ID# 258458

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with non-small cell lung cancer (NSCLC) advanced or metastatic non-squamous (NSQ) NSCLC with available tissue specimens.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 15 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H24-281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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