計劃書編號BO28984
試驗已結束
2015-01-01 - 2024-11-26
Phase III
終止收納6
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
在未曾接受治療、間變性淋巴瘤激酶陽性的晚期非小細胞肺癌患者中，比較ALECTINIB和CRIZOTINIB的隨機分組、多中心、第三期、開放標示試驗
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試驗申請者
台灣中外製藥股份有限公司
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試驗委託 / 贊助單位名稱
F. HOFFMANN-LA ROCHE LTD.
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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
實際收案人數
0 終止收納
實際收案人數
0 終止收納
實際收案人數
0 終止收納
適應症
Anaplastic lymphoma kinasepositive (ALK-positive) nonsmall cell lung cancer (NSCLC)
試驗目的
療效目的
本試驗的主要療效目的如下：
在未曾接受治療的間變性淋巴瘤激酶（anaplastic lymphoma kinase，ALK）陽性晚期非小細胞肺癌（non-small cell lung cancer，NSCLC）患者中，以試驗主持人評量之無惡化存活時間（progression-free survival，PFS）為指標，評估並比較alectinib和crizotinib的療效
安全性目的
本試驗之安全性目的如下：
評估alectinib相較於crizotinib的安全性和耐受性
藥品名稱
硬空膠囊劑
主成份
Alectinib
劑型
030
劑量
150
評估指標
Efficacy Outcome Measures
The efficacy outcome measures for this study are as follows:
PFS, which is defined as the time from randomization to the first documented disease progression, as determined by the investigators (primary endpoint) or IRC (secondary endpoint) using RECIST v1.1 or death from any cause, whichever occurs first. Patients without an event will be censored at the last tumor assessment either during follow up or during study treatment. Patients with no post baseline assessments will be censored at the date of randomization.
ORR, which is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response, as determined by the investigators using RECIST v1.1. Patients without any assessments will be regarded as non responders.
Time to CNS progression, which is defined as the time from randomization to the first occurrence of disease progression in the CNS as determined by IRC using RECIST v1.1 and RANO (separate assessments and analyses), as well as C-ORR in patients with CNS metastases who have measurable disease in the CNS at baseline, C-DOR in patients who have a CNS Objective Response, and C-PR at 6, 12, 18, and 24 months.
DOR, which is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first). This will only be calculated for patients who have a best overall response of CR or PR. Patients who do not progress or die after they have had a response are censored at the date of their last tumor measurement.
OS, which is defined as the time from randomization to death from any cause. Patients without an event will be censored at the last date known to be alive. Patients without any follow up information will be censored at the date of randomization.
Safety Outcome Measures
The secondary safety outcome measures for this study are as follows:
Serious and non-serious adverse events
Safety laboratory tests values
The efficacy outcome measures for this study are as follows:
PFS, which is defined as the time from randomization to the first documented disease progression, as determined by the investigators (primary endpoint) or IRC (secondary endpoint) using RECIST v1.1 or death from any cause, whichever occurs first. Patients without an event will be censored at the last tumor assessment either during follow up or during study treatment. Patients with no post baseline assessments will be censored at the date of randomization.
ORR, which is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response, as determined by the investigators using RECIST v1.1. Patients without any assessments will be regarded as non responders.
Time to CNS progression, which is defined as the time from randomization to the first occurrence of disease progression in the CNS as determined by IRC using RECIST v1.1 and RANO (separate assessments and analyses), as well as C-ORR in patients with CNS metastases who have measurable disease in the CNS at baseline, C-DOR in patients who have a CNS Objective Response, and C-PR at 6, 12, 18, and 24 months.
DOR, which is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first). This will only be calculated for patients who have a best overall response of CR or PR. Patients who do not progress or die after they have had a response are censored at the date of their last tumor measurement.
OS, which is defined as the time from randomization to death from any cause. Patients without an event will be censored at the last date known to be alive. Patients without any follow up information will be censored at the date of randomization.
Safety Outcome Measures
The secondary safety outcome measures for this study are as follows:
Serious and non-serious adverse events
Safety laboratory tests values
主要納入條件
Inclusion Criteria
Patients must meet the following criteria for study entry:
Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana IHC test. Sufficient tumor tissue to perform ALK IHC and ALK FISH is required. Both tests will be performed at designated central laboratories.
Age 18 years old.
Life expectancy of at least 12 weeks.
ECOG PS of 0 2.
Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
Adequate hematologic function:
Platelet count 100 109/L
ANC 1500 cells/L
Hemoglobin 9.0 g/dL
Adequate renal function:
Calculated creatinine clearance at least 45 mL/min
Patients must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment.
Measurable disease (by RECIST v1.1) prior to the administration of study treatment.
Prior brain or leptomeningeal metastases allowed if asymptomatic and diagnosed incidentally at study baseline. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment at least 14 days before enrollment and be clinically stable.
For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment.
For women who are not postmenopausal ( 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of 1% per year during the treatment period and for at least 3 months after the last dose of study drug. Abstinence is only acceptable if it is in line with the preferred and usual lifesty
Patients must meet the following criteria for study entry:
Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana IHC test. Sufficient tumor tissue to perform ALK IHC and ALK FISH is required. Both tests will be performed at designated central laboratories.
Age 18 years old.
Life expectancy of at least 12 weeks.
ECOG PS of 0 2.
Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
Adequate hematologic function:
Platelet count 100 109/L
ANC 1500 cells/L
Hemoglobin 9.0 g/dL
Adequate renal function:
Calculated creatinine clearance at least 45 mL/min
Patients must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment.
Measurable disease (by RECIST v1.1) prior to the administration of study treatment.
Prior brain or leptomeningeal metastases allowed if asymptomatic and diagnosed incidentally at study baseline. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment at least 14 days before enrollment and be clinically stable.
For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment.
For women who are not postmenopausal ( 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of 1% per year during the treatment period and for at least 3 months after the last dose of study drug. Abstinence is only acceptable if it is in line with the preferred and usual lifesty
主要排除條件
N/A
試驗計畫預計收納受試者人數
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台灣人數
18 人
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全球人數
286 人
