UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024762
Receipt number R000028456
Scientific Title Assessment of surrogate signaling pathways after 1st/2nd and 3rd generation EGFR-TKI treatment in advanced non-small cell lung cancer with EGFR gene mutation -multicenter, prospective observational study-
Date of disclosure of the study information 2017/01/01
Last modified on 2021/11/15 11:43:16

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Basic information

Public title

Assessment of surrogate signaling pathways after 1st/2nd and 3rd generation EGFR-TKI treatment in advanced non-small cell lung cancer with EGFR gene mutation -multicenter, prospective observational study-

Acronym

IGF signal after EGFR-TKI

Scientific Title

Assessment of surrogate signaling pathways after 1st/2nd and 3rd generation EGFR-TKI treatment in advanced non-small cell lung cancer with EGFR gene mutation -multicenter, prospective observational study-

Scientific Title:Acronym

IGF signal after EGFR-TKI

Region

Japan


Condition

Condition

Non-small cell lung cancer with EGFR gene mutation

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Evaluatiopn of IGF signal pathway after 3rd generation EGFR-TKI

Basic objectives2

Others

Basic objectives -Others

response rate
disease control rate
progression free survival
FGF,PFGF,HGF signal pathway
Evaluatiopn of EGFR mutaiton(e.g.T790M,C797S)

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluatiopn of IGF signal pathway after 3rd generation EGFR-TKI

Key secondary outcomes

response rate
disease control rate
progression free survival
FGF,PFGF,HGF signal pathway
Evaluatiopn of EGFR mutaiton(e.g.T790M,C797S)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Histlogically or cytologically confirmed non squamous non small cell lung cancer(NSCLC)
2.Unresectable and metastatic NSCLC
3.Harboring sensitive EGFR mutation(exon19 or exon21) and exon 20 T790M
4. Adequate osimertinib treatment
5. Patients who have treated with one EGFR-TKI
6. More than 20 years old
7. Performance Status (ECOG) 0-2
8. Adequate organ functions
9. No QTc prolongation (within 450msec)
10. Insulin unused diabetic(HbA1<7.0)
11. Life expectancy over 3 months
12. Written informed consent

Key exclusion criteria

1. Preexisting interstitial lung disease
2. Active brain metastasis
3. HBs antigen positive
4. HBs or HBc antibody positive,and HBV-D
NA positive
5. HIV,HCV career
6. Previous treatment history of cytotoxic anti-cancer agents just before osimertinib
7. Active double cancer
8. In use of steroid
9. Infection using antibiotic
10. Disagree of specimen collection
11. Patients whose attending doctor consider as inappropriate for this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Oizumi
Middle name
Last name Satoshi

Organization

Hokkaido Cancer Center

Division name

Respiratory medicine

Zip code

003-0804

Address

Kikusui 4-2, 3-54, Shiroishiku Sapporo

TEL

011-811-9111

Email

soizumi@sap-cc.go.jp


Public contact

Name of contact person

1st name Mizugaki
Middle name
Last name Hidenori

Organization

Hokkaido University Hospital

Division name

First department of medicine

Zip code

060-8648

Address

North 14, West 5, Kita-ku, Sapporo

TEL

011-706-5911

Homepage URL


Email

mhide@pop.med.hokudai.ac.jp


Sponsor or person

Institute

First department of medicine, Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

Nippon Boehringer-Ingelheim Co.,Ltd.
Medical Division

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University Hospital

Address

North 14, West 5, Kita-ku, Sapporo

Tel

011-706-7636

Email

crjimu@huhp.hokudai.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

旭川医科大学(北海道)、旭川医療センター(北海道)、市立旭川病院(北海道)、KKR 札幌医療センター(北海道)、北海道がんセンター(北海道)、北海道大学病院 内科Ⅰ(北海道)、北海道大学病院 腫瘍内科学分野(北海道)、市立札幌病院(北海道)、JCHO北海道病院(北海道)、札幌医科大学医学部(北海道)、手稲渓仁会クリニック(北海道)、王子総合病院(北海道)、苫小牧市立病院(北海道)、岩見沢市立病院(北海道)、北海道中央労災病院(北海道)、帯広厚生病院(北海道)、国立病院機構函館病院(北海道)、福島県立医科大学(福島県)、東北大学病院(宮城県)、仙台厚生病院(宮城県)、宮城県立がんセンター(宮城県)、弘前大学医学部(青森県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 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

Evaluatiopn of IGF signal pathway after 3rd generation EGFR-TKI

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

No longer recruiting

Date of protocol fixation

2016 Year 10 Month 07 Day

Date of IRB

2017 Year 03 Month 02 Day

Anticipated trial start date

2017 Year 03 Month 03 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information

response rate
disease control rate
progression free survival
Evaluatiopn of FGF,PFGF,HGF signal pathway
Evaluatiopn of EGFR mutaiton(e.g.T790M,C797S)


Management information

Registered date

2016 Year 11 Month 08 Day

Last modified on

2021 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028456


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name