Randomized, Open Label, Multicenter, Phase III Study of Entrectinib Versus Crizotinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring ROS1 Gene Rearrangements with and Without Central Nervous System Metastases - MO41552

F. Hoffmann-La Roche AG0 个研究点目标入组 206 人开始时间: 2024年1月15日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Histologically or cytologically-confirmed diagnosis of advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement, No prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC, Prior radiotherapy is allowed if more than 14 days have elapsed between the end of treatment and randomization, Measurable systemic disease according to RECIST v1.1, Participants with measurable and non-measurable CNS lesions per RECIST v1.1, including leptomeningeal carcinomatosis, Life expectancy of at least 12 weeks

•Prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC, NCI-CTCAE v5.0 Grade 3 or higher toxicities due to any prior therapy (excluding alopecia, fatigue, nausea and lack of appetite), which have not shown improvement and are strictly considered to interfere with current study drug, History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction = 50% observed during screening for the study, History of prolonged corrected QTc interval, Peripheral sensory neuropathy = Grade 2, Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis

发起方