Last updated 6 days ago
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)
150 patients around the world
Available in United States, Brazil
AbbVie
2Research sites
150Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Recruiting
SponsorAbbVie
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06568939
