Non Small Cell Lung CancerMETRIXNCT06068842
A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants With Non-Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by AbbVie at 19 sites in 12 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 579 participants
- Where
- 19 sitesin 12 countries
- Study dates
- 3 Nov 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with non-small cell lung cancer (NSCLC) advanced or metastatic non-squamous (NSQ) NSCLC with available tissue specimens.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 12 countries.
19 sites in 12 countries
Canada3 sites
Nova Scotia Health Authority /ID# 256950
Halifax, Nova Scotia, B3H 1V8
Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 257872
Québec, Quebec, G1V 4G5
Royal University Hospital /ID# 261272
Saskatoon, Saskatchewan, S7N 0W8
Argentina2 sites
Hospital Italiano de Buenos Aires /ID# 256999
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., 1199
Instituto Alexander Fleming /ID# 256295
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1426
Brazil2 sites
Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 256487
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital Alemao Oswaldo Cruz /ID# 256486
São Paulo, 01323-020
Japan2 sites
National Cancer Center Hospital /ID# 257889
Chuo-ku, Tokyo, 104-0045
Kindai University Hospital /ID# 257890
Osakasayama-shi, Osaka, 589-8511
Switzerland2 sites
Universitätsspital Basel /ID# 256677
Basel Town, Canton of Basel-City, 4031
University Hospital Zurich /ID# 256678
Zurich, Canton of Zurich, 8006
United Kingdom2 sites
Queen's University Belfast /ID# 258458
Belfast, Northern Ireland, BT9 7AE
University Hospitals Birmingham NHS Foundation Trust /ID# 260991
Birmingham, B15 2TH
China1 site
West China Hospital, Sichuan University /ID# 256906
Chengdu, Sichuan, 610041
South Korea1 site
The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 261511
Seoul, Seoul Teugbyeolsi, 07345
Spain1 site
UOMi Cancer Center - Clinica Tres Torres /ID# 261212
Barcelona, 08017
Taiwan1 site
National Taiwan University Hospital /ID# 261542
Taipei City, Taipei, 100
United Arab Emirates1 site
Burjeel Medical City /ID# 259407
Abu Dhabi, 0
About this study
Official title: 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.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, Telisotuzumab Vedotin, ABBV-399, Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start3 Nov 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068842
- Sponsor's protocol ID
- H24-281
- Acronym
- METRIX
- Status last verified
- Jan 2025
- First submitted
- 29 Sep 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Real-World Study of MET Overexpression in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06068842
- Acronym / sponsor ID
- METRIX / H24-281
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, Telisotuzumab Vedotin, ABBV-399, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with non-small cell lung cancer (NSCLC) advanced or metastatic non-squamous (NSQ) NSCLC with available tissue specimens.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
19 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by AbbVie at 19 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada, Argentina, Brazil, Japan, Switzerland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Mesenchymal Epithelial Transition (MET) protein overexpression (OE) (time frame: Up to 15 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.