Status:
RECRUITING
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)
Lead Sponsor:
AbbVie
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Projected life expectancy of at least 12 weeks.
- Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie 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
- Adenosquamous or neuroendocrine histology, or sarcomatoid features.
- Actionable EGFR activating 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.
Key Trial Info
Start Date :
January 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06568939
Start Date
January 20 2025
End Date
February 1 2028
Last Update
December 22 2025
Active Locations (58)
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1
Ironwood Cancer & Research Center /ID# 276370
Chandler, Arizona, United States, 85224
2
Valkyrie Clinical Trials /ID# 271322
Los Angeles, California, United States, 90067
3
Yale New Haven Hospital /ID# 271584
New Haven, Connecticut, United States, 06510
4
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
Jacksonville, Florida, United States, 32256