A Phase 3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer Expressing c-Met Protein Level Above a Defined Cutoff
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- AbbVie
- 入组人数
- 660
- 主要终点
- Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
研究概览
简要总结
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to evaluate whether telisotuzumab adizutecan improves response rate and overall survival compared to standard of care in participants with epidermal growth factor receptor (EGFR) wildtype non-squamous NSCLC who have high c-Met protein expression and have progressed after standard therapies.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This is an open-label study where participants and doctors know which treatment is being administered. Participants are randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan, while the other group will receive standard of care (SOC) treatment consisting of Docetaxel or Docetaxel with Ramucirumab. Around 660 participants will be enrolled in the study at approximately 250 sites worldwide.
Participants will receive either doses of Intravenous (IV) telisotuzumab adizutecan or IV SOC of docetaxel alone or docetaxel with ramucirumab. The study will run for a duration of approximately 50 months.
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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
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
- •Histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC
- •Known EGFR activating mutation status (EGFR wildtype only; participants with EGFR activating mutations are not eligible)
- •Cellular-mesenchymal epithelial transition (c-Met) Immunohistochemistry (IHC) staining as assessed by AbbVie designated IHC Laboratory
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 that has not been previously irradiated
排除标准
- •Participant tumor(s) has (have) mixed adenosquamous or squamous or neuroendocrine histology or sarcomatoid features
- •Known active/symptomatic brain metastases
- •History of interstitial lung disease (ILD) or pneumonitis that required systemic steroids
- •Major, life-threatening medical conditions with life expectancy less than 3 months
- •Clinically significant medical conditions or other reasons that would interfere with study participation
研究组 & 干预措施
Telisotuzumab Adizutecan
Participants will receive telisotuzumab adizutecan until meeting study drug discontinuation criteria.
干预措施: Telisotuzumab Adizutecan (Drug)
Standard of care (SOC)
Participants will receive SOC docetaxel or docetaxel plus ramucirumab until meeting study drug discontinuation criteria.
干预措施: Ramucirumab (Drug)
Standard of care (SOC)
Participants will receive SOC docetaxel or docetaxel plus ramucirumab until meeting study drug discontinuation criteria.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
时间窗: Up to Approximately 24 Months
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or partial response (PR) per BICR based on RECIST version 1.1.
Overall Survival (OS)
时间窗: Up to Approximately 50 Months
OS is defined as the time from date of randomization to the event of death from any cause.
次要结局
- Progression-Free Survival (PFS) Based on BICR Assessment Per RECIST Version 1.1(Up to Approximately 24 Months)
- Duration of Response (DoR) Based on BICR Assessment Per RECIST Version 1.1(Up to Approximately 24 Months)
- Disease Control (DC) Based on BICR Assessment Per RECIST Version 1.1(Up to Approximately 24 Months)
- Change From Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Up to Week 12)
- Change From Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)(Up to Week 12)
- Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) as Measured by the EORTC QLQ-C30(Up to Week 12)