NCT06568939RecruitingPhase 2
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)
A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 22 Aug 2024
- Start date
- 20 Jan 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- AbbVie
- Diseases
- Lung cancer
- NCT number
- NCT06568939
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 20 Jan 2025 to the primary completion date, Feb 2028
- 83 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
- 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.
- Active uncontrolled bacterial or viral infection.
- Active corneal disorder.
Lab values
- EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations).
Other
- Adenosquamous or neuroendocrine histology, or sarcomatoid features.
- Grade \>= 2 edema or lymphedema.
- Grade \>= 2 ascites or pleural effusion.
- Grade \>= 2 neuropathy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (83)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cto - Centro De Tratamento Oncologico /ID# 276699 Coordinator of this site? Confirm its status | Belém | Brazil | Recruiting |
| Ictrials Pesquisa E Desenvolvimento /ID# 276681 Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Cepen - Centro De Pesquisa E Ensino Em Oncologia De Santa Catarina /ID# 273204 Coordinator of this site? Confirm its status | Florianópolis | Brazil | Recruiting |
| Suporte Nutricional e Quimioterapia LTDA - PRONUTRIR /ID# 273203 Coordinator of this site? Confirm its status | Fortaleza | Brazil | Recruiting |
| Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 272513 Coordinator of this site? Confirm its status | Ijuí | Brazil | Recruiting |
| Liga Norte Riograndense Contra O Cancer /ID# 273183 Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Hospital De Cancer De Pernambuco /ID# 276104 Coordinator of this site? Confirm its status | Recife | Brazil | Recruiting |
| Hospital Alemao Oswaldo Cruz - Sao Paulo /ID# 272512 Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Beijing Chest Tumor Hospital /ID# 271935 Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Fujian Province Cancer Hospital /ID# 276178 Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Harbin Medical University Cancer Hospital /ID# 271665 Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| LinYi Cancer Hospital /ID# 272068 Coordinator of this site? Confirm its status | Linyi | China | Recruiting |
| The First Affiliated Hospital of Nanchang University /ID# 271666 Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931 Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933 Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
| Union Hospital - Tongji Medical College /ID# 271668 Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928 Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Henan Cancer Hospital /ID# 271927 Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Rambam Health Care Campus- Haifa /ID# 270078 Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center /ID# 270095 Coordinator of this site? Confirm its status | Jerusalem | Israel | Completed |
| Meir Medical Center /ID# 270071 Coordinator of this site? Confirm its status | Kefar Sava | Israel | Recruiting |
| Rabin Medical Center. /ID# 270087 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| The Chaim Sheba Medical Center /ID# 270068 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Fujieda Municipal General Hospital /ID# 277025 Coordinator of this site? Confirm its status | Fujieda | Japan | Recruiting |
| National Cancer Center Hospital East /ID# 277056 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| Kobe Minimally Invasive Cancer Center /ID# 277469 Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| Kurashiki Central Hospital /ID# 276995 Coordinator of this site? Confirm its status | Kurashiki-shi | Japan | Recruiting |
| University of Miyazaki Hospital /ID# 277020 Coordinator of this site? Confirm its status | Miyazaki | Japan | Recruiting |
| Nagoya University Hospital /ID# 277010 Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Kitasato University Hospital /ID# 277012 Coordinator of this site? Confirm its status | Sagamihara-shi | Japan | Recruiting |
| Hokkaido University Hospital /ID# 277014 Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Sendai Kousei Hospital /ID# 277023 Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Wakayama Medical University Hospital /ID# 276997 Coordinator of this site? Confirm its status | Wakayama | Japan | Recruiting |
| Military Medical Academy /ID# 279873 Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Institute for Oncology and Radiology of Serbia /ID# 270561 Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| University Clinical Center Serbia /ID# 270808 Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Clinical Hospital Center - Bezanijska Kosa /ID# 270558 Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Institute For Pulmonary Diseases Of Vojvodina /ID# 270559 Coordinator of this site? Confirm its status | Kamenitz | Serbia | Recruiting |
| University Clinical Center Kragujevac /ID# 275773 Coordinator of this site? Confirm its status | Kragujevac | Serbia | Recruiting |
| University Clinical Center Nis /ID# 270557 Coordinator of this site? Confirm its status | Niš | Serbia | Recruiting |
| National Cancer Centre Singapore /ID# 271499 Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| National University Hospital /ID# 271700 Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| University Cancer and Blood Center /ID# 270969 Coordinator of this site? Confirm its status | Athens | United States | Recruiting |
| Ironwood Cancer and Research Center /ID# 276370 Coordinator of this site? Confirm its status | Chandler | United States | Recruiting |
| Medical University of South Carolina /ID# 273272 Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| University of Illinois Hospital and Health Sciences System /ID# 275345 Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Texas Oncology - Dallas - Worth Street /ID# 278947 Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Astera Cancer Care /ID# 272359 Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| Virginia Cancer Specialists - Fairfax /ID# 272004 Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Saint Francis Cancer Center - Greenville /ID# 276368 Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Kaiser Permanente Moanalua Medical Center /ID# 272916 Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899 Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Nebraska Hematology-Oncology /ID# 272970 Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| University of Arkansas for Medical Sciences /ID# 272923 Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Valkyrie Clinical Trials /ID# 271322 Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Start Los Angeles /ID# 284999 Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Northwest Georgia Oncology Centers /ID# 275374 Coordinator of this site? Confirm its status | Marietta | United States | Recruiting |
| SCRI Oncology Partners /ID# 270162 Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Yale New Haven Hospital /ID# 271584 Coordinator of this site? Confirm its status | New Haven | United States | Completed |
| Illinois Cancer Specialists /ID# 274678 Coordinator of this site? Confirm its status | Niles | United States | Recruiting |
| Ocala Oncology Center /ID# 273697 Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| Community Cancer Trials Of Utah /ID# 276598 Coordinator of this site? Confirm its status | Ogden | United States | Recruiting |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527 Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 284816 Coordinator of this site? Confirm its status | Oxnard | United States | Recruiting |
| Memorial Hospital West /ID# 270313 Coordinator of this site? Confirm its status | Pembroke Pines | United States | Recruiting |
| OSF St. Francis Medical Center /ID# 281591 Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Mercy Health - Perrysburg Cancer Center /ID# 270536 Coordinator of this site? Confirm its status | Perrysburg | United States | Recruiting |
| FirstHealth of the Carolinas- Speciality Center /ID# 272924 Coordinator of this site? Confirm its status | Pinehurst | United States | Recruiting |
| Renown Regional Medical Center /ID# 273535 Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Memorial University Medical Center /ID# 272467 Coordinator of this site? Confirm its status | Savannah | United States | Completed |
| Guthrie Robert Packer Hospital /ID# 270316 Coordinator of this site? Confirm its status | Sayre | United States | Recruiting |
| Medical Oncology Associates - Spokane /ID# 277172 Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Springfield Clinic - First /ID# 272576 Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Comprehensive Hematology Oncology /ID# 270422 Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Florida Cancer Specialists - North /ID# 271995 Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Northwest Medical Specialties Tacoma /ID# 270534 Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| Regional Cancer Care Associates /ID# 270783 Coordinator of this site? Confirm its status | Teaneck | United States | Recruiting |
| Montefiore Medical Center - Einstein Campus /ID# 277169 Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Texas Oncology - Northeast Texas /ID# 272000 Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| Clinical Research Alliance (SMO/Network/Consortium) /ID# 270455 Coordinator of this site? Confirm its status | Westbury | United States | Recruiting |
| Florida Cancer Specialists - East /ID# 271993 Coordinator of this site? Confirm its status | West Palm Beach | United States | Recruiting |
| Cancer Care Associates Of York /ID# 270971 Coordinator of this site? Confirm its status | York | United States | Recruiting |
| Genesis Healthcare System /ID# 273361 Coordinator of this site? Confirm its status | Zanesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.