Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
Phase II, Open Label, Single Arm Study of the Efficacy and Safety of Crizotinib in East Asian Patients With Advanced ALK-Negative NSCLC Harboring a Translocation or Inversion Involving the c-ROS Oncogene (ROS1) Locus
1 other identifier
interventional
129
4 countries
44
Brief Summary
To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2013
Longer than P75 for phase_2
44 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
September 5, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedStudy Start
First participant enrolled
September 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2015
CompletedResults Posted
Study results publicly available
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2020
CompletedFebruary 21, 2021
February 1, 2021
1.8 years
September 5, 2013
July 28, 2016
February 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Independent Radiology Reviewed Overall Objective Response (ORR)
Overall objective response (ORR) was defined as the number of patients with a best overall response of confirmed Complete Response or confirmed Partial Response according to RECIST v1.1 (as determined by Independent Radiology Review \[IRR\]), relative to the total population of response-evaluable participants. Per RECIST v1.1, CR: disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Confirmed responses were those that persisted on repeat imaging at least 4 weeks after the initial documentation of response.
Starting from the first dose study treatment until the first documented CR or PR (every 8 weeks then after 8 cycles at every 12 weeks in duration of 94.0 weeks)
Secondary Outcomes (10)
IRR-Assessed Duration of Response (DR)
From first documentation of objective tumor response to first documentation of objective PD or death due to any cause, whichever occurred first (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks)
IRR-Assessed Time to Tumor Response (TTR)
From date of first dose of crizotinib to first documentation of objective response was observed (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks)
IRR Assessed Disease Control Rate (DCR) at 8 Weeks
At 8 weeks after the start of study treatment
IRR-Assessed Progression Free Survival (PFS)
From the date of first dose of crizotinib until the first documentation of objective PD or death (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks)
Overall Survival (OS)
From date of the first dose of crizotinib until the date of death from any cause (up to 291.9 weeks)
- +5 more secondary outcomes
Study Arms (1)
Crizotinib
EXPERIMENTALSingle-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
- treatment-naïve or have received no more than 3 systemic treatment regimen(s)
- Positive for translocation or inversion events involving the ROS1 gene
- Negative for translocation or inversion events involving the ALK gene
- Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
- Any prior treatment (chemotherapy, radiation \[except for palliative\], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
- At least 1 measurable tumor lesion as per RECIST v1.1
- Female or male, 18 years of age or older
- ECOG performance status 0 to 1
- Adequate organ function
- Signed and dated informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
- Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment
You may not qualify if:
- Current treatment on another therapeutic clinical trial
- Prior therapy specifically directed against ALK or ROS1 fusion genes
- Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
- known interstitial fibrosis or interstitial lung disease
- myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
- Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade \>/=2, uncontrolled atrial fibrillation of any grade, or QTc \>470 msec
- Pregnant or breast feeding
- Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
- Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
- Evidence of active malignancy within last 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- OxOnc Development LPcollaborator
Study Sites (44)
The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology
Hefei, Anhui, 230022, China
Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chaoyang District, Beijing Municipality, 100021, China
The Military General Hospital of Beijing PLA / Medical Oncology Dept.
Dongcheng District, Beijing Municipality, 100700, China
307 Hospital of PLA/Department of Lung Cancer
Fengtai District, Beijing Municipality, 100071, China
Beijing Cancer Hospital, Department of Thoracic Oncology
Haidian District, Beijing Municipality, 100142, China
Chinese PLA General Hospital
Haidian District, Beijing Municipality, 100853, China
Beijing Chest Hospital
Tongzhou District, Beijing Municipality, China
Respiration department,the First Affiliated Hospital of Third Military Medical University, PLA
Shapingba District, Chongqing Municipality, 400038, China
Fujian Province Oncology Hospital
Fuzhou, Fujian, 350014, China
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Hunan Provincial Tumor Hospital/Division of Oncology
Changsha, Hunan, 410013, China
Department of Oncology, Jilin Provincial Cancer Hospital
Changchun, Jilin, China
The affiliated hospital of medical college Qingdao University / Medical oncology department
Qingdao, Shandong, 266101, China
Department of Pulmonary Medicine, Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanghai Chest Hospital/Lung cancer clinical center
Shanghai, Shanghai Municipality, 200030, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Zhongshan Hospital Fudan University / Respiratory Department
Xuhui District, Shanghai Municipality, 200032, 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 Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital
Hexi District, Tianjin Municipality, 300060, China
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
Aichi Cancer Center Hospital
Aichi, Japan
National Cancer Center Hospital East
Chiba, Japan
NHO Shikoku Cancer Center
Ehime, Japan
NHO Kyushu Cancer Center
Fukuoka, Japan
Hyogo Cancer Center
Hyōgo, Japan
Tohoku University Hospital
Miyagi, Japan
Kinki University Hospital
Osaka, Japan
Osaka City General Hospital
Osaka, Japan
Cancer Institute Hospital of JFCR
Tokyo, Japan
National Cancer Center Hospital
Tokyo, Japan
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Yonsei University, Severance Hospital
Seoul, South Korea
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Related Publications (1)
Wu YL, Yang JC, Kim DW, Lu S, Zhou J, Seto T, Yang JJ, Yamamoto N, Ahn MJ, Takahashi T, Yamanaka T, Kemner A, Roychowdhury D, Paolini J, Usari T, Wilner KD, Goto K. Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 May 10;36(14):1405-1411. doi: 10.1200/JCO.2017.75.5587. Epub 2018 Mar 29.
PMID: 29596029DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to small percentage of participants (less than 20%) after Cycle 60, data for EORTC QLQ-C30 score and EORTC QLQ-LC13 score could not be interpreted. 65 participants died during the whole study: 15 participants died within 28 days from last dose of study treatment and were reported as SAEs, while 50 participants died during the survival follow-up.
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 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2013
First Posted
September 18, 2013
Study Start
September 30, 2013
Primary Completion
July 31, 2015
Study Completion
January 22, 2020
Last Updated
February 21, 2021
Results First Posted
August 1, 2016
Record last verified: 2021-02