EUCTR2021-001811-94-DK进行中（未招募）1 期
A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 698
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject must have c-Met overexpressing NSCLC as assessed by an AbbVie designated IHC laboratory using the VENTANA MET (SP44) RxDx assay
- •Archival or fresh tumor material must be submitted for assessment of c-Met levels by an AbbVie designated IHC laboratory during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, fresh biopsy material may be submitted for reassessment of c-Met expression.
- •- If a subject 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
- •Subject has adequate bone marrow, renal, and hepatic function
- •Subject must have histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
- •Subjects must have a known EGFR activating mutation status.
- •-Subjects with actionable EGFR activating mutations are not eligible.
- •Subjects with actionable alterations in genes other than EGFR are eligible.
- •Subject must have measurable disease per RECIST version 1.1.
- •Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- •Subject must 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 would count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
- •Subject must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:
- •- Subjects WITHOUT an actionable gene alteration: subjects must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
- •- Subjects WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): subjects must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
- •- Subjects 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).
- •Subject must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
- •No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction [PCR]) test or 2 negative antigen test
- •results at least 24 hours apart. Subject must not have had any serious SARS-CoV-2 infection that required mechanical ventilation/endotracheal intubation or extracorporeal membrane oxygenation (ECMO) support in the past 6 months, or long-term complications from SARS-CoV-2 infection that are not resolved at the time of prescreening.
- •Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen for the study after they meet the SARS-CoV-2 infection viral clearance criteria listed in the protocol.
排除标准
- •Subject has adenosquamous histology.
- •Subject has received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.
- •Subject has received prior docetaxel therapy.
- •Subjects 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.
- •Subjects with 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.
- •Subject with 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 CT scan.
- •History of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •Subject with unresolved AE = Grade 2 from prior anticancer therapy, except for alopecia or anemia.
- •Subject has had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
- •Subjects with the following:
- •- Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board.
- •- Active hepatitis B virus (HBV) infection, defined by HBV DNA = 500 IU/mL or hepatitis B surface antigen (HBsAG) positivity associated with HBV DNA = 500 IU/mL. In subjects with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening if required by local regulatory authority or ethics committee/institutional review board.
- •- Active hepatitis C virus (HCV) infection, defined by HCV RNA positivity. Subjects cured of HCV infection may be included in the study. In subjects with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening if required by local regulatory authority or ethics committee/institutional review board.
- •- Uncontrolled autoimmune disease.
- •Subject has clinically significant condition(s) including but not limited to the following:
- •- Clinically significant vascular disease, including:
- •- Myocardial infarction within 1 year or stroke within 6 months prior to first dose of study drug, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV), cardiac arrhythmia (CTCAE Version 5 Grade 2 or higher), or clinically
- •significant electrocardiogram (ECG) abnormalities.
- •- Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) > 470 msec.
- •- Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.
- •- Grade = 2 edema or l
研究者
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