A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
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
1 other identifier
interventional
207
5 countries
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2012
Longer than P75 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedStudy Start
First participant enrolled
September 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2015
CompletedResults Posted
Study results publicly available
March 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2020
CompletedDecember 8, 2020
November 1, 2020
2.8 years
July 10, 2012
June 8, 2016
November 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Based on IRR by Treatment Arm
PFS was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression (by IRR) or death on study due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Progression is defined using RECIST v1.1, as at least a 20% increase (including an absolute increase of at least 5 millimeters) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)
Secondary Outcomes (19)
Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months)
Overall Survival (OS)
From randomization to death or last date known as alive for those who were lost to follow-up or withdrew consent (assessed up to 64 months).
Percentage of Participants With Disease Control at 12 Weeks Based on IRR
From randomization to Week 12
Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months
From randomization to 1 year and from randomization to 18 months
Duration of Response (DR) Based on IRR
From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months)
- +14 more secondary outcomes
Study Arms (2)
Crizotinib
EXPERIMENTALCrizotinib
Chemotherapy
ACTIVE COMPARATORChemotherapy \[Option at Investigator's Choice\]
Interventions
250 mg two times daily \[BID\], oral, on a continuous daily dosing schedule. Cycles are defined in 21 day periods.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (47)
The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology
Hefei, Anhui, 230002, China
Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Dept. of Respiration. Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
Oncology Department, the Second Affiliated Hospital of Third Military Medical University,PLA
Chongqing, Chongqing Municipality, 400037, China
Oncology Department, XinQiao Hospital of Third Military Medical University,
Chongqing, Chongqing Municipality, 400037, China
Fujian Province Oncology Hospital
Fuzhou, Fujian, 350014, China
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangdong General Hospital, Oncology Center
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Guangzhou Medical College/Thoracic Surgery
Guangzhou, Guangdong, 510120, China
Department 2 of Chemotherapy, Tumour Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center
Wuhan, Hubei, 430030, China
Hunan Provincial Tumor Hospital/Division of Oncology
Changsha, Hunan, 410013, China
Nanjing General Hospital of Nanjing Military Command, Department of Respiratory medicine
Nanjing, Jiangsu, 210002, China
Department of Oncology, Jilin Provincial Cancer Hospital
Changchun, Jilin, 130012, China
The first hospital of China Medical University/Oncology Department
Shenyang, Liaoning, 110001, China
Oncology Department, West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Province Cancer Hospital/Department of Pulmonary Tumor
Chengdu, Sichuan, 610041, China
Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
Hangzhou, Zhejiang, 310016, China
307 Hospital of PLA/Department of Lung Cancer
Beijing, 100071, China
Beijing Cancer Hospital
Beijing, 100142, China
The Military General Hospital of Beijing PLA
Beijing, 100700, China
Peking Union Medical College Hospital
Beijing, 100730, China
Chinese PLA General Hospital
Beijing, 100853, China
Beijing Chest Hospital, Capital Medical University
Beijing, 101149, China
Respiration department,the First Affiliated Hospital of Third Military Medical University, PLA
Chongqing, 400038, China
Shanghai Chest Hospital/Lung cancer clinical center
Shanghai, 200030, China
Shanghai Chest Hospital
Shanghai, 200030, China
Zhongshan Hospital Fudan University / Respiratory Department
Shanghai, 200032, China
Shanghai First People's Hospital
Shanghai, 200080, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
Pamela Youde Nethersole Eastern Hospital
Chai Wan, 0, Hong Kong
Queen Mary Hospital
Hong Kong, 0, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Department of Nuclear Medicine, Radiotherapy and Oncology, Hospital Universiti Sains Malaysia
Kubang Kerian, Kota Bahru, Kelantan, 16150, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
Chi Mei Medical Center Liouying
Liou Ying Township, Tainan, 736, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
Chi Mei Medical Center Liuying
Tainan, 736, Taiwan
Taipei Veterans General Hospital, Chest Department
Taipei, 11217, Taiwan
Chang Gung Medical Foundation, LinKou Branch
Taoyuan District, 333, Taiwan
Medical Oncology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Pathumwan, Bangkok, 10330, Thailand
Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,
Bangkok, 10700, Thailand
Related Publications (1)
Wu YL, Lu S, Lu Y, Zhou J, Shi YK, Sriuranpong V, Ho JCM, Ong CK, Tsai CM, Chung CH, Wilner KD, Tang Y, Masters ET, Selaru P, Mok TS. Results of PROFILE 1029, a Phase III Comparison of First-Line Crizotinib versus Chemotherapy in East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2018 Oct;13(10):1539-1548. doi: 10.1016/j.jtho.2018.06.012. Epub 2018 Aug 14.
PMID: 29966800DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2012
First Posted
July 12, 2012
Study Start
September 29, 2012
Primary Completion
June 30, 2015
Study Completion
January 8, 2020
Last Updated
December 8, 2020
Results First Posted
March 13, 2017
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.