A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Recruiting · NCT06568939 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 80 to 90 sites worldwide. Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Projected life expectancy of at least 12 weeks.
- Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as \>= 25% tumor cells with 3+ staining (high \[\>= 50% 3+\]; intermediate \[\>= 25% - \< 50%\]) as assessed by a Sponsor designated immunohistochemistry (IHC) laboratory
- Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic.
- Must have a known epidermal growth factor receptor (EGFR) activating mutation status.
- Actionable alterations in genes other than EGFR are permitted.
- Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting, as stated in the protocol.
- Must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol.
Exclusion criteria
- Adenosquamous or neuroendocrine histology, or sarcomatoid features.
- EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations).
- Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.
- Received prior docetaxel therapy.
- Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol.
- History of other malignancies except those stated in the protocol.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, as noted in the protocol.
- Unresolved clinically significant adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
- Major surgery within 21 days prior to randomization.
- Clinically significant condition(s) including but not limited to those listed in the protocol.
- Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.
- Grade \>= 2 edema or lymphedema.
- Grade \>= 2 ascites or pleural effusion.
- Grade \>= 2 neuropathy.
- Active uncontrolled bacterial or viral infection.
- Active corneal disorder.
Where it is running
60 locations listed across 21 US states.
- Ironwood Cancer and Research Center /ID# 276370 - Chandler, Arizona, United States
- University of Arkansas for Medical Sciences /ID# 272923 - Little Rock, Arkansas, United States
- Valkyrie Clinical Trials /ID# 271322 - Los Angeles, California, United States
- FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 284816 - Oxnard, California, United States
- Yale New Haven Hospital /ID# 271584 - New Haven, Connecticut, United States
- Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899 - Jacksonville, Florida, United States
- Ocala Oncology Center /ID# 273697 - Ocala, Florida, United States
- Memorial Hospital West /ID# 270313 - Pembroke Pines, Florida, United States
- Comprehensive Hematology Oncology /ID# 270422 - St. Petersburg, Florida, United States
- Florida Cancer Specialists - North /ID# 271995 - St. Petersburg, Florida, United States
- Florida Cancer Specialists - East /ID# 271993 - West Palm Beach, Florida, United States
- University Cancer & Blood Center /ID# 270969 - Athens, Georgia, United States
- Northwest Georgia Oncology Centers /ID# 275374 - Marietta, Georgia, United States
- Memorial University Medical Center /ID# 272467 - Savannah, Georgia, United States
- Kaiser Permanente Moanalua Medical Center /ID# 272916 - Honolulu, Hawaii, United States
- University of Illinois Hospital and Health Sciences System /ID# 275345 - Chicago, Illinois, United States
- Illinois Cancer Specialists /ID# 274678 - Niles, Illinois, United States
- Springfield Clinic - First /ID# 272576 - Springfield, Illinois, United States
- Nebraska Hematology-Oncology /ID# 272970 - Lincoln, Nebraska, United States
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527 - Omaha, Nebraska, United States
- Renown Regional Medical Center /ID# 273535 - Reno, Nevada, United States
- Astera Cancer Care /ID# 272359 - East Brunswick, New Jersey, United States
- Regional Cancer Care Associates /ID# 270783 - Teaneck, New Jersey, United States
- Montefiore Medical Center - Einstein Campus /ID# 277169 - The Bronx, New York, United States
- Clinical Research Alliance - Westbury /ID# 270455 - Westbury, New York, United States
- FirstHealth of the Carolinas- Speciality Center /ID# 272924 - Pinehurst, North Carolina, United States
- Mercy Health - Perrysburg Cancer Center /ID# 270536 - Perrysburg, Ohio, United States
- Genesis Healthcare System /ID# 273361 - Zanesville, Ohio, United States
- Guthrie Robert Packer Hospital /ID# 270316 - Sayre, Pennsylvania, United States
- Cancer Care Associates Of York /ID# 270971 - York, Pennsylvania, United States
- Medical University of South Carolina /ID# 273272 - Charleston, South Carolina, United States
- Saint Francis Cancer Center - Greenville /ID# 276368 - Greenville, South Carolina, United States
- SCRI Oncology Partners /ID# 270162 - Nashville, Tennessee, United States
- Texas Oncology - Dallas - Worth Street /ID# 278947 - Dallas, Texas, United States
- Texas Oncology - Northeast Texas /ID# 272000 - Tyler, Texas, United States
- Community Cancer Trials Of Utah /ID# 276598 - Ogden, Utah, United States
- Virginia Cancer Specialists - Fairfax /ID# 272004 - Fairfax, Virginia, United States
- Medical Oncology Associates - Spokane /ID# 277172 - Spokane, Washington, United States
- Northwest Medical Specialties Tacoma /ID# 270534 - Tacoma, Washington, United States
- Rambam Health Care Campus- Haifa /ID# 270078 - Haifa, Israel
- Shaare Zedek Medical Center /ID# 270095 - Jerusalem, Israel
- National University Hospital /ID# 271700 - Singapore, Singapore
- Hospital Alemao Oswaldo Cruz - Sao Paulo /ID# 272512 - São Paulo, Brazil
- Nagoya University Hospital /ID# 277010 - Nagoya, Aichi-ken, Japan
- Beijing Chest Tumor Hospital /ID# 271935 - Beijing, Beijing Municipality, China
- Institute for Oncology and Radiology of Serbia /ID# 270561 - Belgrade, Beograd, Serbia
- Military Medical Academy /ID# 279873 - Belgrade, Beograd, Serbia
- University Clinical Center Serbia /ID# 270808 - Belgrade, Beograd, Serbia
- Clinical Hospital Center - Bezanijska Kosa /ID# 270558 - Belgrade, Beograd, Serbia
- Suporte Nutricional e Quimioterapia LTDA - PRONUTRIR /ID# 273203 - Fortaleza, Ceará, Brazil
- Meir Medical Center /ID# 270071 - Kefar Sava, Central District, Israel
- Rabin Medical Center. /ID# 270087 - Petah Tikva, Central District, Israel
- National Cancer Centre Singapore /ID# 271499 - Singapore, Central Singapore, Singapore
- National Cancer Center Hospital East /ID# 277056 - Kashiwa-shi, Chiba, Japan
- Fujian Province Cancer Hospital /ID# 276178 - Fuzhou, Fujian, China
- Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931 - Nanning, Guangxi, China
- Harbin Medical University Cancer Hospital /ID# 271665 - Harbin, Heilongjiang, China
- Henan Cancer Hospital /ID# 271927 - Zhengzhou, Henan, China
- Hokkaido University Hospital /ID# 277014 - Sapporo, Hokkaido, Japan
- Union Hospital - Tongji Medical College /ID# 271668 - Wuhan, Hubei, China
Showing 60 of 80 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →