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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 768
- 试验地点
- 634
- 主要终点
- Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
研究概览
简要总结
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 determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. 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 telisotuzumab vedotin or docetaxel at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 768 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 evaluable tumor material is available (Except China).
- •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.
- •An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •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 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 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 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.
排除标准
- •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 must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..
- •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 tomography (CT) scan or prior pneumonectomy. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
- •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 dose of replacement hormone are eligible for study.
- •Major surgery within 21 days prior to randomization.
- •Clinically significant condition(s) as listed in the protocol.
研究组 & 干预措施
Docetaxel
Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.
干预措施: Docetaxel (Drug)
Telisotuzumab Vedotin
Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
干预措施: Telisotuzumab Vedotin (Biological)
结局指标
主要结局
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
时间窗: Up to approximately 39 months
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause.
Overall Survival (OS)
时间窗: Up to approximately 39 months
OS is defined as the time from randomization to the event of death from any cause.
次要结局
- Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.(Up to approximately 12 Weeks)
- PFS per Investigator Assessment(Up to approximately 58.25 months)
- Change from Baseline of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).(Up to approximately 12 Weeks)
- Objective Response Rate (ORR), per BICR.(Up to approximately 58.25 months)
- Duration of Response (DoR), per BICR(Up to approximately 58.25 months)