UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030697