A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
This trial is active, not recruiting.
|Condition||nsclc (non-small cell lung cancer)|
|Treatments||crizotinib, pemetrexed/cisplatin, pemetrexed/carboplatin|
|Targets||ALK, c-MET, ROS1|
|Start date||September 2012|
|End date||June 2015|
|Trial size||207 participants|
|Trial identifier||NCT01639001, A8081029|
This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer Patients. The objective of the study is to demonstrate that Crizotinib is superior to first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma Kinase) gene locus.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Hefei, China||The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology||no longer recruiting|
|Beijing, China||Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences||no longer recruiting|
|Beijing, China||Dept. of Respiration. Peking Union Medical College Hospital||no longer recruiting|
|Chongqing, China||Oncology Department, XinQiao Hospital of Third Military Medical University,||no longer recruiting|
|Fuzhou, China||Fujian Province Oncology Hospital||no longer recruiting|
|Guangzhou, China||SUN Yat-Sen University Cancer Center||no longer recruiting|
|Guangzhou, China||Guangdong General Hospital, Oncology Center||no longer recruiting|
|Guangzhou, China||The First Affiliated Hospital of Guangzhou Medical College/Thoracic Surgery||no longer recruiting|
|Nanning, China||Department 2 of Chemotherapy, Tumour Hospital of Guangxi Zhuang Autonomous Region||no longer recruiting|
|Wuhan, China||Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center||no longer recruiting|
|Changsha, China||Hunan Provincial Tumor Hospital/Division of Oncology||no longer recruiting|
|Nanjing, China||Nanjing General Hospital of Nanjing Military Command, Department of Respiratory medicine||no longer recruiting|
|Changchun, China||Department of Oncology, Jilin Provincial Cancer Hospital||no longer recruiting|
|Shenyang, China||The first hospital of China Medical University/Oncology Department||no longer recruiting|
|Chengdu, China||Oncology Department, West China Hospital of Sichuan University||no longer recruiting|
|Chengdu, China||Sichuan Province Cancer Hospital/Department of Pulmonary Tumor||no longer recruiting|
|Hangzhou, China||Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University||no longer recruiting|
|Hangzhou, China||Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology||no longer recruiting|
|Beijing, China||307 Hospital of PLA/Department of Lung Cancer||no longer recruiting|
|Beijing, China||Beijing Cancer Hospital||no longer recruiting|
|Beijing, China||The Military General Hospital of Beijing PLA||no longer recruiting|
|Beijing, China||Chinese PLA General Hospital||no longer recruiting|
|Beijing, China||Beijing Chest Hospital, Capital Medical University||no longer recruiting|
|Chongqing, China||Respiration department,the First Affiliated Hospital of Third Military Medical University, PLA||no longer recruiting|
|Shanghai, China||Shanghai Chest Hospital/Lung cancer clinical center||no longer recruiting|
|Shanghai, China||Shanghai Chest Hospital||no longer recruiting|
|Shanghai, China||Zhongshan Hospital Fudan University / Respiratory Department||no longer recruiting|
|Shanghai, China||Shanghai First People's Hospital||no longer recruiting|
|Tianjin, China||Tianjin Medical University Cancer Institute and Hospital||no longer recruiting|
|Chai Wan, Hong Kong||Pamela Youde Nethersole Eastern Hospital||no longer recruiting|
|Hong Kong, Hong Kong||Queen Mary Hospital||no longer recruiting|
|Shatin, Hong Kong||Prince of Wales Hospital||no longer recruiting|
|Kubang Kerian, Kota Bahru, Malaysia||Department of Nuclear Medicine, Radiotherapy and Oncology, Hospital Universiti Sains Malaysia||no longer recruiting|
|Georgetown, Malaysia||Hospital Pulau Pinang||no longer recruiting|
|Liou Ying Township, Taiwan||Chi Mei Medical Center Liouying||no longer recruiting|
|Taichung, Taiwan||Chung Shan Medical University Hospital||no longer recruiting|
|Taipei, Taiwan||Taipei Veterans General Hospital, Chest Department||no longer recruiting|
|Taoyuan, Taiwan||Chang Gung Medical Foundation, LinKou Branch||no longer recruiting|
|Pathumwan, Thailand||Medical Oncology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University||no longer recruiting|
|Bangkok, Thailand||Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Progression-Free Survival (PFS) based on Response Evaluation Criterion in Solid Tumors [RECIST] version 1.1 (documented by independent radiology laboratory)
time frame: From randomization to date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Follow-up will continue for 18 months after last patient is randomized or until required number of PFS events is observed.
Objective Response Rate (ORR) (confirmed by independent radiology review)
time frame: From randomization to complete response (CR) or partial response (PR). Up to 18 months follow-up or until required number of PFS events is observed.
Duration of Response (DR)
time frame: From first documentation of objective tumor response (CR or PR) to first documentation of objective tumor progression or to death. Up to 18 months follow-up or until required number of PFS events is observed.
Overall Survival (OS)
time frame: From randomization to the date of death due to any cause. Follow-up will continue until death or 36 months after the randomization of the last patient.
Time To Deterioration (TTD)
time frame: From randomization to deterioration while on study treatment. Up to 18 months follow-up or until required number of PFS events is observed.
Health Related Quality of Life (HRQoL)
time frame: Cycle 1 day 1 to end of treatment or withdrawal or crossover.
Time To Progression (TTP)
time frame: From the date of randomization to the date of the first documentation of objective tumor progression. Up to 18 months follow-up or until required number of PFS events is observed.
Intracranial Time To Progression (IC-TTP)
time frame: From the date of randomization to the date of the first documentation of objective tumor progression but only considering intracranial disease. Up to 18 months follow-up or until required number of PFS events is observed.
Extracranial Time To Progression (EC-TTP)
time frame: From the date of randomization to the date of the first documentation of objective tumor progression but only considering extracranial disease. Up to 18 months follow-up or until required number of PFS events is observed.
time frame: At 1 year and at 18 months, after the date of randomization.
Disease Control Rate (DCR)
time frame: At 12 weeks, after the date of randomization. Up to 18 months follow-up or until required number of PFS events is observed.
Time to Tumor Response (TTR)
time frame: From randomization to the date of the first documentation of objective tumor progression. Up to 18 months follow-up or until required number of PFS events is observed.
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - 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 for at least 2 weeks and are not taking any medications contraindicated in Exclusion Criteria - 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. Exclusion Criteria: - 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 CYP3A inducers/inhibitors Concurrent use of drugs that are CYP3A substrates with narrow therapeutic indices. - Known HIV infection - History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis. - Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal disease on hemodialysis, 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.
|Official title||Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated East Asian Patients With Non-Squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus|
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