計劃書編號A7471017
試驗已結束
2009-11-01 - 2012-12-31
Phase II
終止收納3
ICD-10C34.90
未明示側性支氣管或肺惡性腫瘤
ICD-10C34.91
右側支氣管或肺惡性腫瘤
ICD-10C34.92
左側支氣管或肺惡性腫瘤
ICD-10C7A.090
支氣管及肺惡性類癌
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9162.9
支氣管及肺惡性腫瘤
開放標籤之第2期臨床試驗，評估PF-00299804用於不抽菸或曾有輕微菸癮之未經治療的晚期肺腺癌病患
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試驗委託 / 贊助單位名稱
N/A
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
適應症
肺癌
試驗目的
於不抽菸或有輕微菸癮之未經治療的晚期肺腺癌病患，評估使用 PF-00299804的安全性及療效
藥品名稱
錠劑
主成份
PF-00299804
劑型
110
劑量
30 mg/ 45 mg
評估指標
To assess the clincial benefit by measure Progression-free survival at 4-months(PFS4mo)
主要納入條件
Inclusion Criteria
1.Histologically confirmed, advanced NSCLC
2.No prior treatment with systemic chemotherapy for advanced disease
3.Age 18 years and must be non-smoker or light smoker
4.ECOG 0-1 performance status
5.Lesion size is measurable and is encouraged to meet the RECIST criteria
6.Adequate organ function.
1.Histologically confirmed, advanced NSCLC
2.No prior treatment with systemic chemotherapy for advanced disease
3.Age 18 years and must be non-smoker or light smoker
4.ECOG 0-1 performance status
5.Lesion size is measurable and is encouraged to meet the RECIST criteria
6.Adequate organ function.
主要排除條件
Exclusion Criteria
1.Patient with known active brain metastases or any leptomeningeal metastases ;
2.Uncontrolled or significant cardiovascular disease;
3.Have prior malignancy within the last 5 years;
4.Pregnant, planning to be pregnant or partner planning to be pregnant;
5.Current enrollment in another therapeutic clinical trial.
1.Patient with known active brain metastases or any leptomeningeal metastases ;
2.Uncontrolled or significant cardiovascular disease;
3.Have prior malignancy within the last 5 years;
4.Pregnant, planning to be pregnant or partner planning to be pregnant;
5.Current enrollment in another therapeutic clinical trial.
試驗計畫預計收納受試者人數
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台灣人數
10 人
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全球人數
80 人
