UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

AstraZeneca KK

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

05

Month

30

Day

Last modified on

2022

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031562