UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031845
Receipt number R000036359
Scientific Title Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Date of disclosure of the study information 2018/03/22
Last modified on 2020/09/25 09:55:16

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Basic information

Public title

Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer

Acronym

Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer

Scientific Title

Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer

Scientific Title:Acronym

Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer

Region

Japan


Condition

Condition

Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the factor of resistance to afatinib in EGFR gene mutation positive NSCLC. To investigate the frequency of T790M mutation and concordance rate between blood and tumor tissue at PD

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The frequency of T790M mutation and concordance rate between blood and tumor tissue at PD

Key secondary outcomes

1) PFS
2) ORR
3) TTF
4) OS
5) Safety
6) The correlation between blood concentration of afatinib and safety


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

Afatinib 40mg/day

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) Patients with NSCLC with a histological diagnosis or cytodiagnosis
2) Patients with EGFR gene mutation
3) Patients with unresectable advanced case
4) Patients that 14 days pass from the last dosage of systemic chemotherapy
5) Patients with more than 20 years old
6) Patients with ECOG PS 0,1,2
7) Patients harboring a more than one measurable lesion
8) Patients that expected survival time is more than 2 months
9) Patients with adequate organ function
Neutrophil >= 1500/mm3
Platelet >= 100,000/mm3
Hemoglobin >= 8.0g/dl
AST,ALT <=2.5 x ULN
Total bilirubin <= 2mg/dl
10) Patients providing written informed consent

Key exclusion criteria

1) Patients with interstitial pneumonitis or pulmonary fibrosis
2) Patients with serious infection
3) Patients with unsteady angina or cardiac infarction
4) Patients with severe complication
5) Patients with active double cancer
6) Patients requiring medication influenced P glycoprotein
7) Patients with history of dosage afatinib
8) Patients with contraindication against afatinib
9) Patients with history of serious hypersensitivity or allergy
10) Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby
11) Patients with complication with mental disease or a mind symptom, and are judged to have difficulty in participation in the study
12) Any other patients who are regarded as unsuitable for this study by the investigators

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Keiko
Middle name
Last name Mizuno

Organization

Kagoshima University Hospital

Division name

Department of Pulmonary medicine

Zip code

890-8520

Address

8-35-1, Sakuragaoka, Kagoshima-city

TEL

99-275-5111

Email

keim@m.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Keiko
Middle name
Last name Mizuno

Organization

Kagoshima University Hospital

Division name

Department of Pulmonary medicine

Zip code

890-8520

Address

8-35-1, Sakuragaoka, Kagoshima-city

TEL

099-275-5111

Homepage URL


Email

keim@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Nippon Boehringer Ingelheim Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee on Clinical Research, Kagoshima University Hospital

Address

8-35-1, Sakuragaoka, Kagoshima-city

Tel

099-275-5111

Email

kufsyomu@kuas.kagoshima-u.ac.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

鹿児島大学病院(鹿児島県)
川内市医師会立市民病院(鹿児島県)
南九州病院(鹿児島県)
鹿児島市立病院(鹿児島県)
鹿児島厚生連病院(鹿児島県)
今給黎総合病院(鹿児島県)
南風病院(鹿児島県)
鹿児島県立北薩病院(鹿児島県)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 22 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

26

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

2017 Year 02 Month 24 Day

Date of IRB

2017 Year 09 Month 15 Day

Anticipated trial start date

2017 Year 09 Month 15 Day

Last follow-up date

2020 Year 08 Month 30 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 22 Day

Last modified on

2020 Year 09 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036359


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name