UMIN-CTR Clinical Trial

Public title

Mathematical Modeling-based Medication for Minimizing Malignant evolution of Lung Cancer

Acronym

M5-LC

Scientific Title

Mathematical Modeling-based Medication for Minimizing Malignant evolution of Lung Cancer

Scientific Title:Acronym

M5-LC

Region

Japan

Condition

EGFR mutation-positive lung adenocarcinoma

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To understand the dynamics of lung cancer evolution, by means of longitudinal ctDNA monitoring and simulation-based approach, in the course of EGFR-TKI therapy in patients with EGFR mutation-positive lung cancer.

Basic objectives2

Others

Basic objectives -Others

To verify appropriate therapeutic strategy and therapeutic sequence in the management of patients with EGFR mutation-positive lung cancer.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Mathematical modeling to understand the dynamics of lung cancer evolution.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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) Estimated life expectancy > 3 months
2) Written informed consent for participation in this study is obtained
3) Patients with stage IV, recurrent or Stage IIIB/C, without any indication for radical radiation therapy, lung adenocarcinoma who received no prior chemotherapy.
4) Lung adenocarcinoma that is histologically or cytologically diagnosed as well as confirmed as EGFR mutation positive by the validated methods for the detection of EGFR mutations.
5) Patients who are judged suitable for Afatinib therapy by investigators.
6) Measurable disease as defined by RECIST guideline (ver. 1.1)

Key exclusion criteria

1) History of any type of malignancy within the past 5 years (including carcinoma in situ).
2) History of organ transplantation (including hematopoietic stem cell transplantation)
3) Major surgery within one month prior to the first blood sampling in this study.
4) Radiotherapy for brain metastatic or other locally advanced lesions within two weeks prior to the first blood sampling in this study.
5) Concomitant presence of distinct types of lung cancer is confirmed:
- Patients with histologically distinct types of lung cancer, including lung squamous cell carcinoma and small cell lung cancer, will be excluded.
- Patients with distinct lung adenocarcinomas harboring ALK translocation or ROS1 translocation will be excluded.

Target sample size

5

Name of lead principal investigator

1st name
Middle name
Last name	Shunichi Sugawara

Organization

Sendai Kosei Hospital

Division name

Respiratory medicine

Zip code

Address

4-15, Hirosemachi, Aoba-ku, Sendai-shi, Miyagai-ken, Japan

TEL

81-22-222-6181

Email

swara357@sendai-kousei-hospital.jp

Name of contact person

1st name
Middle name
Last name	Tomoiki Aiba

Organization

Sendai Kosei Hospital

Division name

Respiratory medicine

Zip code

Address

4-15, Hirosemachi, Aoba-ku, Sendai-shi, Miyagai-ken, Japan

TEL

81-22-222-6181

Homepage URL

Email

tomowithkk@gmail.com

Institute

Sendai Kosei Hospital

Institute

Department

Personal name

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Division of Health Medical Computational Science, Health Intelligence Center, The Institute of Medical Science, The University of Tokyo
Genomedia Inc.

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

2018

Year

04

Month

20

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

Preinitiation

Date of protocol fixation

2018

Year

04

Month

18

Day

Date of IRB

Anticipated trial start date

2018

Year

11

Month

15

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

2019

Year

03

Month

31

Day

Date analysis concluded

2019

Year

05

Month

31

Day

Other related information

Recruitment of study subjects:
Among newly-treated patients as EGFR mutation-positive lung adenocarcinoma in Sendai Kosei hospital from July 2018 to March 2019, those who meet the inclusion and exclusion criteria can be the study subjects.

Registered date

2018

Year

04

Month

14

Day

Last modified on

2018

Year

10

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036704