UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of DFP-14323 with low dose EGFR-TKI for EGFR mutation positive NSCLC.
Acronym	Phase II study of DFP-14323
Scientific Title	Phase II study of DFP-14323 with low dose EGFR-TKI for EGFR mutation positive NSCLC.
Scientific Title:Acronym	Phase II study of DFP-14323
Region	Japan

Condition
Condition	NSCLC
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety of DFP-14323 with low dose EGFR-TKI for EGFR mutation positive NSCLC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Disease Control Rate(DCR)
Key secondary outcomes	Efficacy 1)Objective Response Rate 2)Nuetrophil/Lymphocyte Rate 3)Tumor Maker Safety Rate of AE and SE

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	DFP-14323 Afatinib20mg 72weeks
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with 1) Histological NSCLC 2) Stage III/IV 3) exon19 del/ exon21 L858R 4) Measurable lesions 5) First line chemo 6) Normal major organ's function 7) PS0-2 8) Life Expectancy 3M 9) Age 20-84 10) Capable of treatment with oral medicine 11) ECG within 4w 12) IC
Key exclusion criteria	Patients without 1) Contraindicated cases for Erlotinib or Afatinib or Osimertinib 2) Obvious infections 3) T790M, exon20 ins 4) Severe heart diseases 5) Severe complications 6) Brain metasitases 7) Severe digestive diseases 8) Severe thromboembolisms 9) Severe diarrhea 10) Severe psychosis
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Hiroshige Middle name Last name Yoshioka
Organization	Kansai Medical University
Division name	Thoracic Oncology
Zip code	573-1191
Address	2-3-1,Shinmachi,Hirakata-Cty,Osaka
TEL	072-804-0101
Email	hgyoshioka@gmail.com

Public contact
Name of contact person	1st name Tsuneo Middle name Last name Suzuki
Organization	Delta-Fly Pharma, Inc.
Division name	Domestic R&D
Zip code	108-0023
Address	3-11-5, Nihonbashihoncho, Chuo-ku, Tokyo
TEL	03-6231-1278
Homepage URL
Email	tsuzuki1206@delta-flypharma.co.jp

Sponsor
Institute	Delta-Fly Pharma, Inc.
Institute
Department

Funding Source
Organization	Delta-Fly Pharma, 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	Delta-Fly Pharma, Inc.
Address	3-11-5, Nihonbashihoncho, Chuo-ku, Tokyo
Tel	03-6231-1278
Email	tsuzuki1206@delta-flypharma.co.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	北野病院（大阪府）他8施設

Other administrative information
Date of disclosure of the study information	2018 Year 06 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	No longer recruiting
Date of protocol fixation	2018 Year 04 Month 05 Day
Date of IRB	2018 Year 05 Month 08 Day
Anticipated trial start date	2018 Year 06 Month 20 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry	2022 Year 06 Month 30 Day
Date trial data considered complete	2022 Year 06 Month 30 Day
Date analysis concluded	2022 Year 08 Month 31 Day

Other
Other related information	2018/9/29 addition of Osimertinib as concomitant 2018/11/6 IRB approved 2019/03/12 Observation 24w->72w Concomitant=Afatinib Only

Management information
Registered date	2018 Year 06 Month 20 Day
Last modified on	2022 Year 06 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037700