A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

September 29, 2012

Primary Completion Date

June 30, 2015

Study Completion Date

January 8, 2020

Conditions
NSCLC (Non-small Cell Lung Cancer)
Interventions
DRUG

Crizotinib

250 mg two times daily \[BID\], oral, on a continuous daily dosing schedule. Cycles are defined in 21 day periods.

DRUG

Pemetrexed/Cisplatin

Option 1: Pemetrexed/Cisplatin; Pemetrexed, 500 mg/m\^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Cisplatin, 75 mg/m\^2 will be administered by infusion after adequate hydration according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and cisplatin will be repeated every 3 weeks for a maximum of 6 cycles.

DRUG

Pemetrexed/Carboplatin

Option 2: Pemetrexed/Carboplatin. Pemetrexed, 500 mg/m\^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Carboplatin, at a dose calculated to produce an AUC of 5 or 6 mg.min/mL will be administered by infusion according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and carboplatin will be repeated every 3 weeks for a maximum of 6 cycles.

Trial Locations (47)

0

Pamela Youde Nethersole Eastern Hospital, Chai Wan

Queen Mary Hospital, Hong Kong

333

Chang Gung Medical Foundation, LinKou Branch, Taoyuan District

402

Chung Shan Medical University Hospital, Taichung

736

Chi Mei Medical Center Liouying, Liou Ying Township

Chi Mei Medical Center Liuying, Tainan City

10330

Medical Oncology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Pathumwan

10700

Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,, Bangkok

10990

Hospital Pulau Pinang, George Town

11217

Taipei Veterans General Hospital, Chest Department, Taipei

16150

Department of Nuclear Medicine, Radiotherapy and Oncology, Hospital Universiti Sains Malaysia, Kubang Kerian, Kota Bahru

100021

Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing

100032

Dept. of Respiration. Peking Union Medical College Hospital, Beijing

Peking Union Medical College Hospital, Beijing

100071

307 Hospital of PLA/Department of Lung Cancer, Beijing

100142

Beijing Cancer Hospital, Beijing

100700

The Military General Hospital of Beijing PLA, Beijing

100730

Peking Union Medical College Hospital, Beijing

100853

Chinese PLA General Hospital, Beijing

Chinese PLA General Hospital, Beijing

101149

Beijing Chest Hospital, Capital Medical University, Beijing

Beijing Chest Hospital, Capital Medical University, Beijing

110001

The first hospital of China Medical University/Oncology Department, Shenyang

130012

Department of Oncology, Jilin Provincial Cancer Hospital, Changchun

200030

Shanghai Chest Hospital/Lung cancer clinical center, Shanghai

Shanghai Chest Hospital, Shanghai

200032

Zhongshan Hospital Fudan University / Respiratory Department, Shanghai

200080

Shanghai First People's Hospital, Shanghai

210002

Nanjing General Hospital of Nanjing Military Command, Department of Respiratory medicine, Nanjing

230002

The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology, Hefei

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

310003

Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou

310016

Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology, Hangzhou

350014

Fujian Province Oncology Hospital, Fuzhou

400037

Oncology Department, the Second Affiliated Hospital of Third Military Medical University,PLA, Chongqing

Oncology Department, XinQiao Hospital of Third Military Medical University,, Chongqing

400038

Respiration department,the First Affiliated Hospital of Third Military Medical University, PLA, Chongqing

410013

Hunan Provincial Tumor Hospital/Division of Oncology, Changsha

430030

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center, Wuhan

510060

SUN Yat-Sen University Cancer Center, Guangzhou

510080

Guangdong General Hospital, Oncology Center, Guangzhou

510120

The First Affiliated Hospital of Guangzhou Medical College/Thoracic Surgery, Guangzhou

530021

Department 2 of Chemotherapy, Tumour Hospital of Guangxi Zhuang Autonomous Region, Nanning

610041

Oncology Department, West China Hospital of Sichuan University, Chengdu

Sichuan Province Cancer Hospital/Department of Pulmonary Tumor, Chengdu

Unknown

Queen Mary Hospital, Hong Kong

Prince of Wales Hospital, Shatin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01639001 - A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients | Biotech Hunter | Biotech Hunter