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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)
698 patients around the world
Available in Argentina, Chile, Mexico, United States, Brazil, Spain
AbbVie
13Research sites
698Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 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 evaluable tumor material is available (Except China).A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.A known epidermal growth factor receptor (EGFR) activating mutation status.Actionable alterations in genes other than EGFR.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.Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.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 chemotherapy).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 ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.Participants with actionable 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 with chemotherapy).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 definitive therapy (such as surgery or radiotherapy) is provided and:There is no evidence of progression of CNS metastases at least 2 weeks after definitive therapy.They are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.
- Participants with adenosquamous histology.Actionable 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.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, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.Unresolved adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.Clinically significant condition(s) as listed in the protocol.
Sites
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Hospital Británico de Buenos Aires - CABA
Recruiting
Centro Médico Austral OMI - CABA
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Instituto de Oncología Ángel H. Roffo - CABA, Buenos Aires
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Instituto de Ensino e Pesquisa São Lucas
Recruiting
Instituto D'or de Pesquisa e Ensino - Rio de Janeiro
Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
SponsorAbbVie
Study typeInterventional
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04928846
