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

NCT06068842 | Completed

• 1 other identifier: H24-281
• Study Type: observational
• Target: 579
• Locations: 12 countries
• Sites: 19

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Telisotuzumab Vedotin; ABBV-399; Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 15 Months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (19)

Hospital Italiano de Buenos Aires /ID# 256999

Ciudad Autonoma Buenos Aires, Buenos Aires F.D., 1199, Argentina

Location

Instituto Alexander Fleming /ID# 256295

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1426, Argentina

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 256487

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Alemao Oswaldo Cruz /ID# 256486

São Paulo, 01323-020, Brazil

Location

Nova Scotia Health Authority /ID# 256950

Halifax, Nova Scotia, B3H 1V8, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 257872

Québec, Quebec, G1V 4G5, Canada

Location

Royal University Hospital /ID# 261272

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

West China Hospital, Sichuan University /ID# 256906

Chengdu, Sichuan, 610041, China

Location

Rambam Health Care Campus /ID# 256546

Haifa, H_efa, 3109601, Israel

Location

Kindai University Hospital /ID# 257890

Osakasayama-shi, Osaka, 589-8511, Japan

Location

National Cancer Center Hospital /ID# 257889

Chuo-ku, Tokyo, 104-0045, Japan

Location

The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 261511

Seoul, Seoul Teugbyeolsi, 07345, South Korea

Location

UOMi Cancer Center - Clinica Tres Torres /ID# 261212

Barcelona, 08017, Spain

Location

Universitätsspital Basel /ID# 256677

Basel Town, Canton of Basel-City, 4031, Switzerland

Location

University Hospital Zurich /ID# 256678

Zurich, Canton of Zurich, 8006, Switzerland

Location

National Taiwan University Hospital /ID# 261542

Taipei City, Taipei, 100, Taiwan

Location

Burjeel Medical City /ID# 259407

Abu Dhabi, 0, United Arab Emirates

Location

Queen's University Belfast /ID# 258458

Belfast, Northern Ireland, BT9 7AE, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust /ID# 260991

Birmingham, B15 2TH, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: November 3, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

KR (1); AE (1); AR (2); GB (2); IL (1); JP (2); BR (2); CH (2); TW (1); CA (3); CN (1); ES (1)