UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Acronym	Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Scientific Title	Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Scientific Title:Acronym	Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To compare the change in clonal heterogeneity between afatinib and gefitinib therapy, and to investigate the correlation of the change in clonal heterogeneity with the efficacy of osimertinib.
Basic objectives2	Others
Basic objectives -Others	Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in clonal heterogeneity upon afatinib or gefinitib treatment.
Key secondary outcomes	The correlation of the clonal heterogeneity with the efficacy of osimertinib.

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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1)Scheduled for osimertinib therapy (80mg/day, daily) 2)To collect an additional 17mL blood before osimertinib therapy is acceptable 3)FFPE tissue sample before afatinib or gefitinib therapy is available 4)Confirmed T790M acquisition at disease progression at 1st line afatinib or gefitinib therapy 5)FFPE tissue sample at the time of disease progression to afatinib or gefitinib therapy is available 6)ECOG performance status: 0 to 2 7)Life expectancy longer than 3 months 8)Adequate organ functions 9)Written informed consent 10)Age >=20 years and <70 years
Key exclusion criteria	1)Administrated other EGFR-TKI before afatinib or gefitinib treatment as 1st line therapy 2)Administrated afatinib or gefitinib as 1st line therapy and recieved other anti-tumor medicine after disease progression before prior to osimertinib therapy 3)Interstitial lung disease or pulmonary fibrosis 4)Active double cancers 5)Uncontrolled abdominal or pericardial effusion or ascites 6)With the following severe comorbidities -Uncontrolled angina, cardiac infarct within three month, or heart failure -Uncontrolled diabetes or hypertension -Severe infection or comorbidities -Significant or recent gastrointestinal disorders whose main symptom is diarrhea -Other complications (e.g. ileus) judged to pose serious obstacles to osimeltinib therapy 7)Women who are pregnant, planning to become pregnant, or breast-feeding. Patients who are unwilling to use contraceptives 8)Patients whose physician assessed inappropriate to the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Miyako Middle name Last name Satouchi
Organization	Hyogo Cancer Center
Division name	Department of Thoracic Oncology
Zip code	6738558
Address	13-70, Kitaoji-cho, Akashi, Hyogo
TEL	078-929-1151
Email	satouchi@hp.pref.hyogo.jp

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Hattori
Organization	Hyogo Cancer Center
Division name	Department of Thoracic Oncology
Zip code	6738558
Address	13-70, Kitaoji-cho, Akashi, Hyogo
TEL	078-929-1151
Homepage URL
Email	hattori@hp.pref.hyogo.jp

Sponsor
Institute	Hyogo Cancer Center
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co ., Ltd.
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	The ethical review boards in Hyogo Cancer Center
Address	13-70, Kitaoji-cho, Akashi, Hyogo
Tel	078-929-1151(ext.440)
Email	hcc-irb@hyogo-cc.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	2018 Year 08 Month 31 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 02 Month 28 Day
Date of IRB	2018 Year 03 Month 12 Day
Anticipated trial start date	2018 Year 09 Month 10 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To compare the change in clonal heterogeneity between afatinib and gefitinib therapy, and to investigate the correlation of the change in clonal heterogeneity with the efficacy of osimertinib.

Management information
Registered date	2018 Year 08 Month 31 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038704