UMIN-CTR Clinical Trial

Basic information
Public title	An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations.
Acronym	An observational study of plasma EGFR mutation status during osimertinib treatment.
Scientific Title	An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations.
Scientific Title:Acronym	An observational study of plasma EGFR mutation status during osimertinib treatment.
Region	Japan

Condition
Condition	lung Cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clear the resistant mechanism of osimertinib treatment for lung cancer harboring EGFR activating and T790M mutations by periodical analysis of EGFR mutations (activating, T790M, and C797S) in circulating tumor DNA using an improved PNA-LNA PCR clamp method.
Basic objectives2	Others
Basic objectives -Others	To evaluate the percentage of the cases emerging C797S mutation in all oseimertinib resistant patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The occurrence ratio of plasma C797S mutations in all osimertinib resistant cases.
Key secondary outcomes	The interval between plasma C797S emerged time and the time of confirmed RECIST PD.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Histologically or cytologically documented non-small cell lung cancer. 2. Stage IIIB or stage IV or recurrent NSCLC 3. Detected EGFR activating mutation (exon 19 deletion or exon 21 L858R) by highly sensitive PCR methods. 4. Have a history of first or second generation EGFR-TKI treatment. 5. Detected T790M mutation by highly sensitive PCR methods. 6. Regarding the patients who have be treated with radiotherapy; 1) Not have received radiotherapy to lesions of lung. 2) More than 12 weeks after receiving radiotherapy to bone metastases in thoracic lesion. 3) More than 2 weeks after receiving radiotherapy to lesions except lung. 7. Regarding the patients who have be treated with therapy as follows; 1) More than 4 weeks after the last operation 2) More than 2 weeks after the last drainage of the pleural space. 3) More than 2 weeks after the last pleurodesis except anticancer drugs 4) More than 3 weeks after the last cytotoxic chemotherapy. 8. Patients who have at least one or more measurable lesion by RESIST (Version1.1) 9. Performance status (ECOG) 0-2 10. Estimated life expectancy at least 3 months. 11. Adequate organ function for osimertinib treatment 12. Written informed consent. 13. Aged over 20 years.
Key exclusion criteria	1. Having an evidence of ILD or pulmonary fibrosis complication on chest X-ray. 2. Having a history or serious complications as bellows: 1) uncontrollable angina pectoris, cardial infarction within 3 months before enrollment, or heart failure. 2) uncontrollable diabetes or hypertension. 3) Severe infectious disease.. 4) gastrointestinal dysfunction with severe diarrhea. 3. Impossible to take drugs orally. 4. Inadequate case considered from drug package insert of osimertinib.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Maemondo
Organization	Miyagi Cancer Center
Division name	Department of respiratory medicine
Zip code
Address	47-1 Nodayama, Medecshima-Shiote, Natori, Japan
TEL	022-384-3151
Email	maemondo-ma693@miyagi-pho.jp

Public contact
Name of contact person	1st name Middle name Last name Tatsuro Fukuhara
Organization	Miyagi Cancer Center
Division name	Department of respiratory medicine
Zip code
Address	47-1 Nodayama, Medecshima-Shiote, Natori, Japan
TEL	022-384-3151
Homepage URL
Email	fukuhara-tatsuro@miyagi-pho.jp

Sponsor
Institute	Miyagi Cancer Center
Institute
Department

Funding Source
Organization	Miyagi Cancer Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of Cancer Biology and Therapeutics, Miyagi Cancer Center Research Institute. Molecular Genetic Research Department, LSI Medience Corporation.
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	2016 Year 12 Month 20 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	Main results already published
Date of protocol fixation	2016 Year 09 Month 25 Day
Date of IRB	2016 Year 10 Month 05 Day
Anticipated trial start date	2016 Year 10 Month 05 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To clear the resistant mechanism of osimertinib treatment for lung cancer harboring EGFR activating and T790M mutations by periodical analysis of EGFR mutations (activating, T790M, and C797S) in circulating tumor DNA using an improved PNA-LNA PCR clamp method. Analysis points are before treatment, every 8 weeks from osimertinib started, and Confirmed RECIST-PD.

Management information
Registered date	2016 Year 12 Month 15 Day
Last modified on	2021 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027819