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 |
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-
IGF signal after EGFR-TKI
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-
IGF signal after EGFR-TKI
Japan |
Non-small cell lung cancer with EGFR gene mutation
Pneumology |
Malignancy
YES
Evaluatiopn of IGF signal pathway after 3rd generation EGFR-TKI
Others
response rate
disease control rate
progression free survival
FGF,PFGF,HGF signal pathway
Evaluatiopn of EGFR mutaiton(e.g.T790M,C797S)
Evaluatiopn of IGF signal pathway after 3rd generation EGFR-TKI
response rate
disease control rate
progression free survival
FGF,PFGF,HGF signal pathway
Evaluatiopn of EGFR mutaiton(e.g.T790M,C797S)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
30
1st name | Oizumi |
Middle name | |
Last name | Satoshi |
Hokkaido Cancer Center
Respiratory medicine
003-0804
Kikusui 4-2, 3-54, Shiroishiku Sapporo
011-811-9111
soizumi@sap-cc.go.jp
1st name | Mizugaki |
Middle name | |
Last name | Hidenori |
Hokkaido University Hospital
First department of medicine
060-8648
North 14, West 5, Kita-ku, Sapporo
011-706-5911
mhide@pop.med.hokudai.ac.jp
First department of medicine, Hokkaido University Hospital
Nippon Boehringer-Ingelheim Co.,Ltd.
Medical Division
Profit organization
Hokkaido University Hospital
North 14, West 5, Kita-ku, Sapporo
011-706-7636
crjimu@huhp.hokudai.ac.jp
NO
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)
2017 | Year | 01 | Month | 01 | Day |
Unpublished
Evaluatiopn of IGF signal pathway after 3rd generation EGFR-TKI
No longer recruiting
2016 | Year | 10 | Month | 07 | Day |
2017 | Year | 03 | Month | 02 | Day |
2017 | Year | 03 | Month | 03 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
response rate
disease control rate
progression free survival
Evaluatiopn of FGF,PFGF,HGF signal pathway
Evaluatiopn of EGFR mutaiton(e.g.T790M,C797S)
2016 | Year | 11 | Month | 08 | Day |
2021 | Year | 11 | Month | 15 | Day |
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 |