CTRI/2022/04/041861进行中（未招募）3 期
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
F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 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
- •2. 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
- •3. Prior radiotherapy is allowed if more than 14 days have elapsed between the end of treatment and randomization. Patients who received brain irradiation must have completed whole brain radiotherapy at least 14 days prior and/or stereotactic radiosurgery at least 7 days prior to the start of entrectinib treatment.
- •4. Measurable systemic disease according to RECIST v1.1
- •5. Life expectancy of at least 12 weeks
- •6. ECOG Performance Status of 0, 1, or 2
- •7. Adequate hematologic, renal, liver functions
- •8. Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
- •9. Ability to swallow entrectinib and crizotinib intact without chewing, crushing, or opening the
- •10. Ability to comply with the study protocol, in the investigator’s judgment
- •11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year during the treatment period and for up to 5 weeks after the last dose of entrectinib or for at least 90 days after the last dose of crizotinib
- •12. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
排除标准
- •1. Current participation in another therapeutic clinical trial
- •2. 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
- •3. 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
- •4. History of recent (within the past 3 months) symptomatic congestive heart failure or ejection
- •fraction ? 50% observed during screening for the study
- •5. History of prolonged corrected QT interval
- •6. History of additional risk factors for torsades de pointes
- •7. Grade = 2 peripheral sensory neuropathy
- •8. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
- •9. Previous malignancy within the past 3 years
- •10. Incomplete recovery from any surgery prior to the start of study treatment that would
- •interfere with the determination of safety or efficacy
- •11. Active GI disease (e.g., Crohn’s disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndrome that would reasonably impact drug absorption
- •12. History of prior therapy-induced pneumonitis
- •13. Any condition (in the past 3 months) e.g., myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, stroke, symptomatic bradycardia, or uncontrolled arrhythmias requiring medication
- •14. Known active infections that would interfere with the assessment of safety or efficacy of
- •study treatments (bacterial, fungal or viral), with the exceptions of HIV, hepatitis B virus
- •(HBV), and hepatitis C virus (HCV) infections
- •15. History of hypersensitivity to any of the additives in the entrectinib and/or crizotinib drug formulations
- •16. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of entrectinib or crizotinib
- •17. Any clinically significant concomitant disease or condition that could interfere with, or for
- •which the treatment might interfere with, the conduct of the study or the absorption of oral
- •medications or that would, in the opinion of the Principal Investigator, pose an unacceptable
- •risk to the patient in this study
- •18. Any psychological, familial, sociological or geographical condition potentially hampering
- •compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
研究者
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