UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Chemotherapy with EGFR-tyrosine kinase inhibitor (EGFR-TKI) or chemotherapy alone in elderly patients with advanced NSCLC with acquired resistance to EGFR-TKI (NEJ017)
Title of the study (Brief title)	NEJ017
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of EGFR-TKI and chemotherapy or chemotherapy alone for elderly or PS 2 patients with advanced NSCLC with acquired resistance to EGFR tyrosine kinase inhibitors
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	progression-free survival
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Chemotherapy and EGFR-TKI
Interventions/Control_2	Chemotherapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with ECOG PS 0-2 and age 70 years or older or PS2 and age younger than 75 years 2)Pathologically or cytlogically confirmed non-small cell lung cancer 3)Patients with clinical stage IIIB unsuitable for radiotherapy, stage IV or recurrent post-operative NSCLC 4) Patients with sensitive EGFR mutation confirmed by sensitive methods such as PNA-LNA PCR clump method 5)Patients with advanced NSCLC and acquired resistance to EGFR-TKIs after achieving stable disease for 6 month or more 6)Patients who had been received EGFR-TKI within 6 weeks of registration of this trial 7)Patients who had received EGFR-TKI only as the previous chemotherapy 8)Patients with evaluable disease defined by RECIST 1.1 9)Patients with adequate organ functions 10)Patients with an estimated survival of at least 3 month 11)Patients with written informed concent
Key exclusion criteria	1)Patients with severe drug allergy 2)Patients with active infection 3)Patients who uses steroids or immunosuppressant drugs 4)Patients with uncontrollable disease 5)Patients with interstitial pneumonia or pulmonary fibrosis on chest CT 6)Patients with massive pleural effusion, ascites, pericardial effusion (drainage or pleurodesis with OK432 or minocylcine are permissive.) 7)Patients who received surgery within 3 weeks or radiotherapy within 2 weeks of registration 8)History of active double cancer within 5 years 9)Patients who have the possibility of pregnancy or in lactation period 10)Patients with symptomatic brain metastases 11)HBs antigen positive 12)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	100

Research contact person
Name of lead principal investigator	Satoshi Oizumi
Organization	Hokkaido University
Division name	First Department of Medicine
Address	N15, W7, Kita-Ku, Sapporo
TEL	011-706-5911
Email	soizumi@med.hokudai.ac.jp

Public contact
Name of contact person	Hajime Asahina
Organization	Hokkaido University
Division name	First Department of Medicine
Address	N15, W7, Kita-Ku, Sapporo
TEL	011-706-5911
Homepage URL
Email	hajime.asahina@gmail.com

Sponsor
Institute	North East Japan Study Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	North East Japan Study Group
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

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 06 Month 20 Day
Anticipated trial start date	2012 Year 07 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 06 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009722