UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Study of Crizotinib in Japanese Patients with Advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive non-small cell lung cancer
Acronym	Phase II Study of Crizotinib in MET alteration+ NSCLC
Scientific Title	Phase II Study of Crizotinib in Japanese Patients with Advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive non-small cell lung cancer
Scientific Title:Acronym	Phase II Study of Crizotinib in MET alteration+ NSCLC
Region	Japan

Condition
Condition	Non-Small Cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the anti-tumor activity and safety of single-agent crizotinib for the treatment of advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive NSCLC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Objective response rate as assessed by independent radiology review (IRR) in advanced MET exon14 skipping mutation-positive or MET high gene copy number-positive NSCLC
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Crizotinib, 250 mg BID Cycles are defined as 28-day periods
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1) Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic. 2) Positive for MET exon 14 skipping mutation or high MET copy number of 7 or more as determined by a validated RT-PCR and/or NGS by a designated central testing laboratory (LC-SCRUM). 3) At least 1 measurable tumor lesion as per RECIST (version 1.1) that has not been irradiated. 4) Female or male, 20 years of age or older. 5) ECOG performance status 0-2. 6) Adequate organ function as defined by the following criteria: 1.Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) <2.5 x upper limit of normal (ULN), or AST and ALT <5 x ULN if liver function abnormalities are due to underlying malignancy; 2.Total serum bilirubin <1.5 x ULN; 3.Absolute neutrophil count (ANC) >1500/microL; 4.Platelets >50,000/microL; 5.Hemoglobin >8.0 g/dL; 6.Serum creatinine <2 x ULN. 7) Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 8) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. 9) Agree to use effective contraception during the study period and for at least 90 days after the last dose of crizotinib (excludes surgically sterile male patients or surgically sterile or postmenopausal female patients).
Key exclusion criteria	Patients presenting with any of the following will not be included in the trial: 1) Current treatment on another therapeutic clinical trial. 2) Characterized ALK or ROS1-positive rearrangement 3) Prior therapy specifically directed against MET 4) Any prior treatment (chemotherapy, radiation or surgery) within 2 weeks prior to study entry. 5) Any > Grade 1 acute toxicity (except alopecia). 6) Symptomatic brain metastases. 7) Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease. 8) Known interstitial fibrosis or interstitial lung disease. 9) 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. 10) Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec. 11) Pregnancy or breastfeeding. 12) Use of drugs or foods after study enrollment that are known potent CYP3A4 inhibitors. 13) Use of drugs after study enrollment that are known potent CYP3A4 inducers. 14) Use of drugs after study enrollment that are CYP3A4 substrates with narrow therapeutic indices. 15) Any other anti-cancer drugs are prohibited. 16) Evidence of active malignancy within the last 3 years. 17) Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study. 18)Patients whom investigator judges to be inappropriate as a participant.
Target sample size	29

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Seto
Organization	National Kyushu Cancer Center
Division name	Department of Thoracic Oncology
Zip code	811-1395
Address	3-1-1 Notame, Minami-ku, Fukuoka
TEL	092-541-3231
Email	setocruise@gmail.com

Public contact
Name of contact person	1st name Kaname Middle name Last name Nosaki
Organization	National Kyushu Cancer Center
Division name	Department of Thoracic Oncology
Zip code	811-1395
Address	3-1-1 Notame, Minami-ku, Fukuoka
TEL	092-541-3231
Homepage URL
Email	qqtg52xd@gmail.com

Sponsor
Institute	National Kyushu Cancer Center
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Kyushu Cancer Center Institutional Review Board
Address	3-1-1 Notame, Minami-ku, Fukuoka
Tel	092-541-3231
Email	601-nkcc-tiken@mail.hosp.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 07 Day
Date of IRB	2018 Year 03 Month 07 Day
Anticipated trial start date	2018 Year 03 Month 24 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 07 Day
Last modified on	2021 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035817