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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026818
Receipt No. 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 2019/09/11

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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
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Meidicne
Division name 2nd division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizouka
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norimichi Akiyama
Organization Hamamatsu University School of Meidicne
Division name 2nd division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizouka
TEL 053-435-2263
Homepage URL
Email nakiyan@hama-med.ac.jp

Sponsor
Institute 2nd division, Department of internal medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization AstraZeneca
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

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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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 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
2019 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030697

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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