UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Title of the study (Brief title)	Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of detection method of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of mutated EGFR from plasma
Key secondary outcomes	T790M mutation rate, Serum HGF, Progression-free survival (PFS), Toxicities

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Detection of mutated EGFR from plasma; gefitinib plus either S-1 or pemetrexed therapy
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 proven non-small cell lung cancer (NSCLC) 2) Stage IIIB or IV disease 3) NSCLC with EGFR mutation (ex19 deletions or L858R) 4) NSCLC resistant to EGFR-TKI (intrinsic or acquired resistance) 5 ) Previously administered EGFR-TKI over 28 days 6) Undergoing EGFR-TKI monotherapy 7) Aged 20 years or older 8) ECOG performance status 0-2 9) One or more measurable lesions 10) No experience of either S-1 or pemetrexed 11) Experience of platinum use or considered to be ineligible for platinum-based therapy 12) Interval of at least 2 weeks from last surgical procedure or radiation therapy 13) Adequate bone marrow, renal, hepatic and cardiopulmonary function 14) Able to take oral medication 15) Life expectancy of at least 12 weeks 16) Written informed consent
Key exclusion criteria	1) Interstital pneumonitis 2) Uncontrolled intercurrent illness 3) Active infection 4) Need for treatment within 6 months for double cancer 5) Symptomatic CNS metastases 6) Massive pleural effusion or ascites 7) History of irradiation to more than half of pelvic bone 8) Allergy to treatment drugs 9) Pregnant or breast-feeding 10) Unwilling to use adequate contraception 11) Other conditions inadequate for this research
Target sample size	26

Research contact person
Name of lead principal investigator	Yukio Hosomi
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Address	3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person	Yusuke Takagi
Organization	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Address	3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization	Tokyo metropolitan government
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 05 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 04 Month 23 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27601920
Results
Other related information

Management information
Registered date	2012 Year 04 Month 23 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009100