UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence. -Phase II study-
Acronym	Effectiveness and feasibility of afatinibe in postoperative recurrent EGFR mutated lung cancer
Scientific Title	Effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence. -Phase II study-
Scientific Title:Acronym	Effectiveness and feasibility of afatinibe in postoperative recurrent EGFR mutated lung cancer
Region	Japan

Condition
Condition	EGFR mutated non-small cell lung cancer patients with postoperative recurrence
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate effectiveness and feasibility of afatinibe in EGFR mutated non-small cell lung cancer patients with postoperative recurrence
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Over all survival Response rate Safety

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients treated with afatinib 40mg per day until disease progression and/or intolerable toxic effect.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Eligible patients had pathologically confirmed NSCLC and non-squamous carcinoma according to American Joint Committee on Cancer criteria. 2)Postoperative recurrent patient and no adaptation of surgery or radiotherapy for recurrent site. 3)Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST) 4)Tumour tissue had to be EGFR mutation-positive at the screening,including common (Leu858Arg, exon 19 deletions) 5)Chemotherapy native patients 6)An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7)Patient have adequate organ function
Key exclusion criteria	Patients were excluded 1)if they had interstitial pneumonia, pneumoconiosis, Radiation pneumonitis, drug-induced pneumonia. 2)Patient had already received EGFR-TKI 3)Patient had uncontrollable pleural effusion, ascites, pericardial effusion 4)Patient had uncontrolled concomitant diseases, baseline organ function. 5)Patients suspected of being pregnant or lactating women 6)Patients had brain tumors and/or brain metastases (symptomatic or requiring treatment) 7)Patients had additional significant malignancies diagnosed within the past 5 years 8)Tumour tissue had to T790M EGFR mutation
Target sample size	38

Research contact person
Name of lead principal investigator	1st name Kimihiro Middle name Last name Shimizu
Organization	Gunma University Graduate School of Medicine
Division name	General surgical science
Zip code	3718511
Address	3-39-15 Showa-machi, maebashi city
TEL	0272208245
Email	kmshimizu@gmail.com

Public contact
Name of contact person	1st name Kai Middle name Last name Obayashi
Organization	Gunma University Graduate School of Medicine
Division name	General surgical science
Zip code	3718511
Address	3-39-15 Showa-machi, maebashi city
TEL	0272208245
Homepage URL
Email	tnagashima82@gmail.com

Sponsor
Institute	Gunma university
Institute
Department

Funding Source
Organization	General surgical science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Gunma university clinical trial department
Address	3-39-15 Showa-machi, maebashi city
Tel	0272208240
Email	mkunimine@gunma-u.ac.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	2014 Year 12 Month 01 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	Preinitiation
Date of protocol fixation	2014 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date	2014 Year 07 Month 10 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 01 Day
Last modified on	2020 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016803