UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026818 |
|---|---|
| Receipt number | R000030697 |
| Scientific Title | Predictive Impact of PD-L1 expression for anti-tumor activity of osimertinib in patients with T790M mutated non-small cell lung cancer |
| Date of disclosure of the study information | 2017/04/19 |
| Last modified on | 2020/04/02 13:48:05 |
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Basic information
Public title
Predictive Impact of PD-L1 expression for anti-tumor activity of osimertinib in patients with T790M mutated non-small cell lung cancer
Acronym
Predictive Impact of PD-L1 expression for osimertinib
Scientific Title
Predictive Impact of PD-L1 expression for anti-tumor activity of osimertinib in patients with T790M mutated non-small cell lung cancer
Scientific Title:Acronym
Predictive Impact of PD-L1 expression for osimertinib
Region
| Japan |
Condition
Condition
non-small cell lung cancer harboring EGFR-T790M mutation after treatment with EGFR-TKI
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal an association between PD-L1 expression on tumor and anti-tumor effect of osimertinib
Basic objectives2
Others
Basic objectives -Others
See above
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine an association between PD-L1 expression in re-biopsied samples and progression free survival with osimertinib
Key secondary outcomes
To explore an association between PD-L1/PD-L2 expression and efficacy of osimertinib
To explore an alteration of PD-L1/L2 expression and CD3 cell infiltration after EGFR-TKI treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Pathologically proven, incurable NSCLC at Stage IIIB or IV
2. Previously treated with EGFR-TKI
3. EGFR-T790M is confirmed by re-biopsy which is performed in clinical practice
4. Patients who will receive osimertinib at 80mg/day
5. Have tissue samples which are evaluable for IHC
6. 20 years or older
7. ECOG-PS 0-2
8. Have signed an informed consent document
Key exclusion criteria
1. Previously treated with osimertinib
2. Previously treated with PD-1/PD-L1 antibody
3. Receiving rifampicin or carbamazepine or St. John's wort and cannot stop.
4. Presence of other active malignancies
5. Pregnant, or have possibility of pregnant, or breast feeding
6. Presence of or have previous history of interstitial lung disease
7. With severe complication which could interfere
8. With active infection including HIV or HBV
9. Unable to have medication per oral
10. Have a history of hypersensitivity with osimeritinib
11. Considered as inadequate for enrollment by primary physician.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Meidicne
Division name
2nd division, Department of Internal Medicine
Zip code
431-3125
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizouka
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Norimichi |
| Middle name | |
| Last name | Akiyama |
Organization
Hamamatsu University School of Meidicne
Division name
2nd division, Department of Internal Medicine
Zip code
431-3125
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizouka
TEL
053-435-2263
Homepage URL
nakiyan@hama-med.ac.jp
Sponsor or person
Institute
2nd division, Department of internal medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seirei Mikatahara General Hospital
National Hospital Organization Tenryu Hospital
Hamamatsu Red Cross Hospital
Hamamatsu Rosai Hospital
JA Shizuoka Kohseiren Enshu Hospital
Iwata city Hospital
Shizuoka General Hospital
Shizuoka City Shimizu Hospital
Shizuoka City Shizuoka Hospital
Shizuoka Saiseikai General Hospital
Fujieda Municipal General Hospital
Hamamatsu Medical Center
Shizuoka Red Cross Hospital
Seirei Hamamatsu General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Meidicne
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizouka
Tel
053-435-2680
rinri@hama-med.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 19 | 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
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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We planned current observational study to evaluate predictive utility of PD-L1 expression on tumor for osimertinib in EGFR-T790M positive NSCLC.
Exploratory, we are also going to evaluate PD-L2 expression and change of PD-L1/L2, CD3 cell infiltration between first- and re-biopsied tissue.
Management information
Registered date
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030697
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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