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Compares treatment options for Non Small Cell Lung Cancer
Official title A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT04928846
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 3: a large, late-stage study
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.
- Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC)...
- Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material...
- If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study...
- A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
You likely can't join if
- Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
- Evidence of leptomeningeal disease.
- Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
- Epidermal growth factor receptor (EGFR) activating mutations.
- Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met...
- Participants who have received prior docetaxel therapy.
See the full eligibility criteria
- Projected life expectancy of at least 12 weeks.
- Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
- Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
- If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient...
- A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
- A known epidermal growth factor receptor (EGFR) activating mutation status. \-- Participants with EGFR activating mutations are not eligible
- Actionable alterations in genes other than EGFR are eligible.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
- Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC
- Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with...
- Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered...
- Participants with gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination...
- Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
- Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
- They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day [QD] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
- Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
- Evidence of leptomeningeal disease.
- Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
- Epidermal growth factor receptor (EGFR) activating mutations.
- Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
- Participants who have received prior docetaxel therapy.
- A history of other malignancies except:
- Malignancy treated with curative intent and with no known active disease present for \>=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants...
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without current evidence of disease.
- A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed...
- Unresolved nor 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...
- Major surgery within 21 days prior to randomization.
- Clinically significant condition(s) as listed in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Yuma, Arizona, United States
- Duarte, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Rancho Mirage, California, United States
- Santa Monica, California, United States
- Jacksonville, Florida, United States
- Ocala, Florida, United States
- Tamarac, Florida, United States
- Savannah, Georgia, United States
- Honolulu, Hawaii, United States
- Elmhurst, Illinois, United States
- Springfield, Illinois, United States
- Goshen, Indiana, United States
- Indianapolis, Indiana, United States
+ 257 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 Birmingham, Alabama, United States; Chandler, Arizona, United States; Phoenix, Arizona, United States; Yuma, Arizona, United States; Duarte, California, United States; Huntington Beach, California, United States and 271 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.