Clinical trial NCT06068842: A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants With Non-Small Cell Lung Cancer
Official title: International Real-World Study of MET Overexpression in Patients With Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
Telisotuzumab Vedotin
ABBV-399
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-05
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence of Mesenchymal Epithelial Transition (MET) protein overexpression (OE)
timeFrame: Up to 15 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires /ID# 256999
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto Alexander Fleming /ID# 256295
state: Ciudad Autonoma De Buenos Aires
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 256487
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz /ID# 256486
city: Halifax
country: Canada
facility: Nova Scotia Health Authority /ID# 256950
state: Nova Scotia
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 257872
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital /ID# 261272
state: Saskatchewan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 256906
state: Sichuan
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 256546
state: H_efa
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 257890
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 257889
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 261511
state: Seoul Teugbyeolsi
city: Barcelona
country: Spain
facility: UOMi Cancer Center - Clinica Tres Torres /ID# 261212
city: Basel Town
country: Switzerland
facility: Universitätsspital Basel /ID# 256677
state: Basel-Stadt
city: Zurich
country: Switzerland
facility: University Hospital Zurich /ID# 256678
state: Zuerich
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 261542
state: Taipei
city: Abu Dhabi
country: United Arab Emirates
facility: Burjeel Medical City /ID# 259407
city: Belfast
country: United Kingdom
facility: Queen's University Belfast /ID# 258458
state: Northern Ireland
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 260991
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: