jRCT2031220047招募中不适用
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
AbbVie G.K.0 个研究点目标入组 698 人开始时间: 2022年5月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 698
- 主要终点
- Progression-Free Survival (PFS) per Independent Central Review (ICR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
- •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.
- •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.
- •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.
- •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 4 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.
排除标准
- •Participants with adenosquamous histology.
- •Actionable epidermal growth factor receptor (EGFR) activating mutations.
- •Participants who have received prior c-Met-targeted antibodies.
- •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 clinically significant 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.
结局指标
主要结局
Progression-Free Survival (PFS) per Independent Central Review (ICR)
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 ICR 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
- Objective Response Rate (ORR)(Up to approximately 58.25 months)
- Duration of Response (DoR)(Up to approximately 58.25 months)
- Time to Deterioration in Cough, Pain or Dyspnea as measured by the Cough, Pain and Dyspnea items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)(Up to approximately 58.25 months)
- PFS per Investigator Assessment(Up to approximately 58.25 months)
- Time to Deterioration of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30)(Up to approximately 58.25 months)
研究者
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