UMIN-CTR Clinical Trial

Basic information
Public title	An Evaluation of tumor response to osimertinib by early FDG-PET finding in patients with T790M positive EGFR mutated non-small cell lung cancer
Acronym	Usefulness of early PET examination in pateients treated with osimertinib
Scientific Title	An Evaluation of tumor response to osimertinib by early FDG-PET finding in patients with T790M positive EGFR mutated non-small cell lung cancer
Scientific Title:Acronym	Usefulness of early PET examination in pateients treated with osimertinib
Region	Japan

Condition
Condition	T790M (detected by cobas EGFR Mutation Test v2) from the relapsed tumor after EGFR-TKI therapy.
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The present study was designed to investigate whether FDG accumulation of FDG-PET examined one week after osimertinib therapy can be a predictive factor in patients with T790M positive NSCLC.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to evaluate the correlation between the SUVmax reduction rate and tumor size reduction rate.
Key secondary outcomes	to evaluate the correlation between the SUVmax reduction rate and progression-free survival (PFS) in targeted lesions.

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	Prevention
Type of intervention	Other
Interventions/Control_1	Before osimertinib therapy, examination of FDG-PET and CT scan are performed and target lesions are determined. We measured the diameter of targeted lesions and maximum uptakes in each lesion (SUVmax). Target lesion is defined as tumor mass located in organs and required at least over 2 cm longitudinal diameter. If there is several target lesions in a subject, up to three targeted lesion in each subject are selected in turn by the biggest size. 2nd examination of FDG-PET will be performed at day 7 after an initiation of osimertinib therapy. The ratio of SUVmax after osimertinib treatment to the SUV max before treatment(SUVmax reduction rate)are calculated in target lesion. The treatment with osimertinib is continued until progression disease (PD). CT was performed every 2 months after starting osimertinib treatment. We measured the minimum tumor diameter of the targeted lesions and calculated reduction rate of tumor.
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	1.age>20 years old 2.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 3.At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) ver 1.1 4.At least two weeks after prior EGFR-TKI therapy or 4 weeks after systemic anticancer therapy 5.Written informed consent 6.adequate hepatic and renal function. Laboratory findings within 7 days before entry described above were as follows; 1)hemoglobin level:more than 9.0g/dL 2)White blood cell:equal to or less than 15000/mm3 3) Neutrophil:more than 1500/mm3 4) Platelet:more than 100000/mm3 5) AST/ALT:equal to or less than 100 IU/L 6) Total bilirubin:equal to or less than 2.0mg/dL 7) Creatinine:equal to or less than 1.5mg/dL 8) Creatinine clearance:more than 50 mL/min(measured value or Cockcroft-Gault formula). 9) SpO2 >92 % 10) Contraceptive measures Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation Male patients should be willing to use barrier contraception.
Key exclusion criteria	1.past history of hypersensitivity to drugs; 2.Double cancers, 3.Severe complications (for example, heart failure, renal failure, liver failure, severe diabetes mellitus, etc.); 4.Active infection including hepatitis B, hepatitis C and HIV. 5.Interstitial lung disease detectable on chest radiography or past history of interstitial lung disease during prior EGFR-TKIs therapy; 6.Pleural, pericardial, or peritoneal effusion requiring drainage; 7.Active brain metastasis; 8.Pregnancy or female with planning pregnancy. Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry 9.Any of the following cardiac criteria: -Mean resting corrected QT interval: >470 msec, -Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) -Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. 10. Treatment history of immune-check point inhibitors
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomonobu Koizumi
Organization	Shinshu University School of Medicine, 3-1-1, Asahi Matsumoto, 390-8621, Japan,
Division name	Department of Comprehensive Cancer Therapy
Zip code
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-2554
Email	tomonobu@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomonobu Koizumi
Organization	Shinshu University School of Medicine, 3-1-1, Asahi Matsumoto, 390-8621, Japan,
Division name	Department of Comprehensive Cancer Therapy
Zip code
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-2554
Homepage URL
Email	tomonobu@shinshu-u.ac.jp

Sponsor
Institute	Department of Comprehensive Cancer Therapy, Shinshu University School of Medicine, 3-1-1, Asahi Matsumoto, 390-8621, Japan,
Institute
Department

Funding Source
Organization	AstraZeneca KK
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 06 Month 03 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	Terminated
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 05 Month 02 Day
Anticipated trial start date	2017 Year 05 Month 31 Day
Last follow-up date	2020 Year 03 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	2017 Year 05 Month 30 Day
Last modified on	2022 Year 12 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031562