Trial Title:
A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants with Non-Small Cell Lung Cancer
NCT ID:
NCT06068842
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non Small Cell Lung Cancer
Telisotuzumab Vedotin
ABBV-399
Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
Adult participants with non-small cell lung cancer (NSCLC) advanced or metastatic
non-squamous (NSQ) NSCLC with available tissue specimens.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Italiano de Buenos Aires /ID# 256999
Address:
City:
Ciudad Autonoma Buenos Aires
Zip:
1199
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Instituto Alexander Fleming /ID# 256295
Address:
City:
Ciudad Autonoma de Buenos Aire
Zip:
1426
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 256487
Address:
City:
Porto Alegre
Zip:
90020-090
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Alemao Oswaldo Cruz /ID# 256486
Address:
City:
Sao Paulo
Zip:
01323-020
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Nova Scotia Health Authority /ID# 256950
Address:
City:
Halifax
Zip:
B3H 1V8
Country:
Canada
Status:
Recruiting
Facility:
Name:
Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 257872
Address:
City:
Québec
Zip:
G1V 4G5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Royal University Hospital /ID# 261272
Address:
City:
Saskatoon
Zip:
S7N 0W8
Country:
Canada
Status:
Recruiting
Facility:
Name:
West China Hospital, Sichuan University /ID# 256906
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Completed
Facility:
Name:
Rambam Health Care Campus /ID# 256546
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital /ID# 257889
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Completed
Facility:
Name:
The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 261511
Address:
City:
Seoul
Zip:
07345
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
UOMi Cancer Center - Clinica Tres Torres /ID# 261212
Address:
City:
Barcelona
Zip:
08017
Country:
Spain
Status:
Recruiting
Facility:
Name:
Universitätsspital Basel /ID# 256677
Address:
City:
Basel Town
Zip:
4031
Country:
Switzerland
Status:
Completed
Facility:
Name:
Burjeel Medical City /ID# 259407
Address:
City:
Abu Dhabi
Zip:
0000
Country:
United Arab Emirates
Status:
Recruiting
Facility:
Name:
Queen's University Belfast /ID# 258458
Address:
City:
Belfast
Zip:
BT9 7AE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University Hospitals Birmingham NHS Foundation Trust /ID# 260991
Address:
City:
Birmingham
Zip:
B15 2TH
Country:
United Kingdom
Status:
Recruiting
Start date:
November 3, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06068842
https://www.abbvieclinicaltrials.com/study/?id=H24-281