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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024762
Receipt No. 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 2017/11/10

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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
Middle name
Last name Satoshi Oizumi
Organization Hokkaido Cancer Center
Division name Respiratory medicine
Zip code
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
Middle name
Last name Hidenori Mizugaki
Organization Hokkaido University Hospital
Division name First department of medicine
Zip code
Address North 14, West 5, Kita-ku, Sapporo
TEL 011-706-5911
Homepage URL
Email mhide@pop.med.hokudai.ac.jp

Sponsor
Institute First department of medicine, Hokkaido University Hospital
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
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
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.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


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