A Phase II, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
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Study 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 Teliso-V in 1 of 2 arms at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin. Approximately 100 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 40 sites worldwide.
Participants will receive IV telisotuzumab vedotin at 1 of 2 doses 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.
CFDA
To evaluate the safety of Telisotuzumab Vedotin at dose levels A and B by measuring the occurrence of adverse events (AEs) of any grade, grade ≥2 AEs, interstitial lung disease (ILD) (any grade and grade ≥2), peripheral neuropathy (any grade and grade ≥2), ocular surface disease (any grade and grade ≥2), AEs leading to discontinuation, and grade 5 AEs. - To evaluate the efficacy of Telisotuzumab Vedotin at dose levels A and B by measuring the objective response (OR) rate. - To evaluate the pharmacokinetics of Telisotuzumab Vedotin. - To evaluate the effects of Telisotuzumab Vedotin at dose levels A and B on patient-reported outcomes.
- 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. CFDA Subjects had to be considered suitable for docetaxel treatment based on the evaluation of the treating physician. For all females/individuals of childbearing potential, a negative serum quantitative pregnancy test result at the Screening Visit and a negative urine pregnancy test at baseline prior to the first dose of study drug. If a patient with a positive serum pregnancy test is not pregnant after follow-up, the subject may be deemed eligible for the study at the discretion of the Investigator in consultation with the AbbVie Medical Monitor. Female subjects/individuals of childbearing potential must use at least 1 effective contraceptive method as specified in the study protocol from study day 1 until at least 7 months after the last dose of study drug. Women/individuals of fertile potential who are not pregnant or lactating and are not considered to be pregnant or donating oocytes during the study period and for approximately 7 months after the last dose of study drug. Sperm producing males/subjects who are capable of impregnating a female/subject of fertile potential and vasectomized subjects must agree to use contraceptive measures as specified in the study protocol from Study Day 1 until 4 months after the last dose of study drug. Sperm-producing males/individuals should not attempt to conceive or donate sperm during the study or for approximately 4 months after the last dose of study drug. Eligible patients are ≥18 years old with c-Met protein OE (≥25% tumor cells at 3+ intensity by immunohistochemistry assay [investigational use only assay for MET (SP44) (Roche)]), a/m non-squamous EGFR WT NSCLC.
- 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.
Clinical Study Information for Healthcare Providers
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