UMIN-CTR Clinical Trial

Basic information
Public title	tudy on Biomarkers Using Circulating Tumor Cells When Administering Osimertinib in Patients with EGFR Mutation-positive Lung Cancer
Acronym	CTC-BIOME
Scientific Title	tudy on Biomarkers Using Circulating Tumor Cells When Administering Osimertinib in Patients with EGFR Mutation-positive Lung Cancer
Scientific Title:Acronym	CTC-BIOME
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the association between progression-free survival (PFS) with osimertinib and the expression of BIM-gamma mRNA in circulating tumor cells (CTC) in patients with EGFR mutation-positive lung cancer.
Basic objectives2	Others
Basic objectives -Others	To clarify biomarkers when administering osimertinib in patients with EGFR mutation-positive lung cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between BIM-gamma mRNA levels in CTC and PFS with osimertinib at baseline
Key secondary outcomes	1) Detection rate of mRNA and DNA of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA , EGFR T790M, C797S, BIM-gamma, EL, L, and S) in CTC and cfDNA 2) Number of CTC extracted 3) Correlation between the expression of BIM-gamma mRNA in CTC and ORR with osimertinib 4) Correlation between the expression of mRNA of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA, EGFR, BIM-EL, L, and S) in CTC and PFS and ORR with osimertinib 5) Correlation between the expression of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA , EGFR, BIM-gamma, EL, L, and S) in cfDNA and PFS and ORR with osimertinib 6) EGFR sensitive mutation and DNA expression of T790M in CTC and cfDNA 7) Detection rate of EGFR C797S mutation in CTC and cfDNA 8) Correlation between mRNA level of BIM-gamma in CTC and PFS of the patients with Osimertininb (during Osimertinib 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) Patients with advanced and postoperative recurrent NSCLC 2) Patients with EGFR sensitive mutation (Del 19, L858R mutation) 3) Patients with tolerance to EGFR-TKI (Gefitinib, Erlotinib, Afatinib) and EGFR T790M mutation 4) Patients with no history of prior treatment with osimertinib and other third-generation EGFR-TKIs 5) Patients who have given informed consent to participate in the study 6) Patients with ECOG performance status of 0 to 2
Key exclusion criteria	1) Patients with complications or a history of serious lung disorder 2) Patients with intermediate or serious liver disorder 3) Patients with complications or a history of serious QT prolongation (QTc value longer than 500msec, symptom of serious arrhythmia) 4) Pregnant women, women who may possibly be pregnant, women who hope to be pregnant, lactating women and men who declined contraception 5) Patients positive for human immunodeficiency virus (HIV) 6) Patients positive for HBs antigen or hepatitis C virus (HCV RNA) 7) Other patients considered as
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazutoshi Isobe
Organization	Toho University School of Medicine
Division name	Division of Respiratory Medicine
Zip code
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL	03-3762-4151
Email	kazutoshiisobe@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazutoshi Isobe
Organization	Toho University School of Medicine
Division name	Division of Respiratory Medicine
Zip code
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL	03-3762-4151
Homepage URL
Email	kazutoshiisobe@med.toho-u.ac.jp

Sponsor
Institute	Toho University
Institute
Department

Funding Source
Organization	AstraZeneca Inc.
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	YES
Study ID_1	ESR-16-12403
Org. issuing International ID_1	AstraZeneca Inc.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 02 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	Completed
Date of protocol fixation	2018 Year 04 Month 02 Day
Date of IRB	2018 Year 04 Month 09 Day
Anticipated trial start date	2018 Year 04 Month 09 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	No information

Management information
Registered date	2018 Year 04 Month 02 Day
Last modified on	2021 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036569