A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination With Paclitaxel and Carboplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer.

Amgen Technology Pvt Ltd0 个研究点目标入组 180 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Men or women 18 years or older with histologically or cytologically confirmed advanced non-squamous NSCLC (unresectable stage IIIB with pericardial or pleural effusion or stage IV/recurrent)
•Measureable disease per RECIST criteria modified
•ECOG performance status of 0 or 1
•Ability to take oral medications
•Competent to give written informed consent

•Current or prior history of CNS metastases
•Any prior chemotherapy for advanced NSCLC
•History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to randomization
•Prior targeted therapies
•Known history of allergy or hypersensitivity to paclitaxel or carboplatin
•History of arterial or venous thrombosis within 52 weeks prior to randomization
•History of bleeding diathesis or non-pulmonary bleeding within 14 days prior to randomization
•Peripheral neuropathy > grade 1 per CTCAE Version 3.0
•Myocardial infarction, cerebrovascular accident, grade 2 or greater peripheral vascular disease, transient ischemic attack, congestive heart failure, percutaneous transluminal coronary angioplasty/stent, ongoing arrythmias requiring medication or unstable angina within 52 weeks prior to randomization
•Any kind of disorder that compromises the ability of the subject to comply with the study procedures
•Uncontrolled hypertension as defined by resting blood pressure > 150/90 mm Hg. Anti-hypertensive medications are allowed if hypertension is stably controlled at the time of randomization
•Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization
•Pregnant or breast feeding women
•Known to be HIV, hepatitis B surface antigen, or hepatitis C positive

发起方

Amgen Technology Pvt Ltd