BridgeMD
New treatment option for Non-Small Cell Lung Cancer
Official 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)
ClinicalTrials.gov ID: NCT06568939
What this study is testing
What is Telisotuzumab Vedotin?
Telisotuzumab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as ABBV-399.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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...
- History of other malignancies except those stated in the protocol.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Ocala, Florida, United States
- Pembroke Pines, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Athens, Georgia, United States
- Marietta, Georgia, United States
- Savannah, Georgia, United States
- Honolulu, Hawaii, United States
- Chicago, Illinois, United States
- Niles, Illinois, United States
- Springfield, Illinois, United States
- Lincoln, Nebraska, United States
- Omaha, Nebraska, United States
- Reno, Nevada, United States
- East Brunswick, New Jersey, United States
+ 54 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States; Ocala, Florida, United States and 68 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.