UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II trial of induction erlotinib followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer.
Title of the study (Brief title)	Personalized Induction Therapy Clinical Trial-3 (PIT-3)
Region	Japan

Condition
Condition	Stage IIIA-N2 EGFR mutated, Non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the saftey and efficacy of erlotinib followed by surgical resection for patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	2-year progression-free survival
Key secondary outcomes	5-year progression-free survival 2-year and 5-year overall survival Completion rate of the protocol treatment Complete resection rate Radiological response rate Down staging rate Safety Pathological response (Ef) Tumor markers (CEA/CYFRA) SUVmax on FDG-PET scan

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	The surgical resection is performed after 8 weeks of oral administration of erlotinib (150mg/day).
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 EGFR mutated (Ex19 deletions or Ex21 L858R) non-small cell lung cancer diagnosed using specimen material obtained from primary tumor or metastastatic lymph node (2) Stage IIIA- pathologically proven N2 disease (3) Without previously treatment for lung cancer (4) Age >=20 (5) ECOG PS 0-1 (6) Expected FEV 1.0 > 800ml after lung resection (7) Adequate organ function (8) Written informed consent
Key exclusion criteria	(1) EGFR mutation T790M postive (2) Interstitial pneumonia or pulmanary fibrosis detectable on chest CT scan (3) Privious history of drug induced lung injury (4) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.) (5) Aactive infection (6) History of congestive heart failure, angina pectoris or myocardial infarction withinthe last 1 year. (7) Unterated bone fracture or serious wound (8) Severe diarrhea (9) Current or previous (within the last 1 year) history of GI perforation or diverticultis (10) Ireus (11) Severe drug allergy (12) Investigational new drug or the unapproved drug is administered (13) History of active double cancer (14) History of pregnancy or lactation (15) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size	25

Research contact person
Name of lead principal investigator	Morihito Okada
Organization	Hiroshima University
Division name	Thoracic Surgery
Address	1-2-3 kasumi minami-ku Hiroshima,Hiroshima
TEL	082-257-5869
Email	morihito1217@gmail.com

Public contact
Name of contact person	Kazuya Takamochi
Organization	Juntendo University
Division name	Thoracic Surgery
Address	3-1-3 Hongo Bunkyo-ku,Tokyo
TEL	03-3813-3111
Homepage URL
Email	ktakamo@juntendo.ac.jp

Sponsor
Institute	Advanced Clinical Trial chest surgery Group (ACTG)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	順天堂大学（東京都） 広島大学（広島）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 10 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2025 Year 02 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 17 Day
Last modified on	2017 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030067