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)
18 Years and older, Male and Female
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 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.
Objectives
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.
Eligibility
- 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.
Treatment Sites in Georgia
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com
6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com
157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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