A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung (PROFILE 1014)(A8081014)

Pfizer Japan Inc.0 个研究点目标入组 334 人开始时间: 2011年3月30日最近更新: 2023年10月17日

试验速览

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•* Histologically or cytologically proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
•* Positive for translocation or inversion events involving the ALK gene locus
•* No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
•* Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.

•* Current treatment on another therapeutic clinical trial.
•* Prior therapy directly targeting ALK
•* Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted
•* Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec
•* Pregnancy or breastfeeding
•* Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors
•* Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices
•* Known HIV infection
•* Known interstitial fibrosis or interstitial lung disease
•* Other severe acute or chronic medical (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

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