Telisotuzumab vedotin for previously treated non-small cell lung cancer
Tests telisotuzumab vedotin at 3 dose regimens in adults with non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Beijing, Fuzhou, Harbin, Linyi, Nanchang, Nanning, Ürümqi, Wuhan, Xi'an, and Zhengzhou, ChinaSee the 10 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with locally advanced or spreading non-small cell lung cancer that has already been treated. The tumour must overexpress c-Met and have no EGFR activating mutation.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-small cell lung cancer that is locally advanced or has spread, with measurable disease. Adenosquamous, neuroendocrine or sarcomatoid types cannot join.
- Earlier treatment
- Must have had no more than 1 line of earlier chemotherapy and must have got worse on at least 1 earlier treatment. Must not have had earlier c-Met-targeted antibodies, telisotuzumab vedotin, certain antibody-drug conjugates or docetaxel.
- Biomarker or test result
- c-Met overexpression: 25% or more of tumour cells with 3+ staining. EGFR status must be known and without activating mutations. Changes in other genes are allowed.
Main reasons for not taking part
- EGFR activating mutations
- Earlier docetaxel or c-Met-targeted treatment
- Brain or spinal cord spread that has not been treated
- Past lung scarring or lung inflammation, such as idiopathic pulmonary fibrosis or pneumonitis
- Active uncontrolled infection or active eye (corneal) disorder
Read by machine on 9 November 2026.
Where in China
- Beijing Chest Tumor Hospital /ID# 271935Beijing, ChinaTaking people
- Fujian Province Cancer Hospital /ID# 276178Fuzhou, ChinaTaking people
- Harbin Medical University Cancer Hospital /ID# 271665Harbin, ChinaTaking people
- LinYi Cancer Hospital /ID# 272068Linyi, ChinaTaking people
- The First Affiliated Hospital of Nanchang University /ID# 271666Nanchang, ChinaTaking people
- Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931Nanning, ChinaTaking people
- Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933Ürümqi, ChinaTaking people
- Union Hospital - Tongji Medical College /ID# 271668Wuhan, ChinaTaking people
- The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928Xi'an, ChinaTaking people
- Henan Cancer Hospital /ID# 271927Zhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AbbVie
- Trial code
- NCT06568939
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations); Adenosquamous or neuroendocrine histology, or sarcomatoid features; Grade >= 2 edema or lymphedema; Grade >= 2 ascites or pleural effusion; Grade >= 2 neuropathy.