UMIN-CTR Clinical Trial

Public title

Chemotherapy with EGFR-tyrosine kinase inhibitor (EGFR-TKI) or chemotherapy alone in elderly patients with advanced NSCLC with acquired resistance to EGFR-TKI (NEJ017)

Acronym

NEJ017

Scientific Title

Chemotherapy with EGFR-tyrosine kinase inhibitor (EGFR-TKI) or chemotherapy alone in elderly patients with advanced NSCLC with acquired resistance to EGFR-TKI (NEJ017)

Scientific Title:Acronym

NEJ017

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

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

Primary outcomes

progression-free survival

Key secondary outcomes

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Oizumi

Organization

Hokkaido University

Division name

First Department of Medicine

Zip code

Address

N15, W7, Kita-Ku, Sapporo

TEL

011-706-5911

Email

soizumi@med.hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Hajime Asahina

Organization

Hokkaido University

Division name

First Department of Medicine

Zip code

Address

N15, W7, Kita-Ku, Sapporo

TEL

011-706-5911

Homepage URL

Email

hajime.asahina@gmail.com

Institute

North East Japan Study Group

Institute

Department

Personal name

Organization

North East Japan Study Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

07

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2012

Year

06

Month

20

Day

Date of IRB

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

Other related information

Registered date

2012

Year

07

Month

06

Day

Last modified on

2016

Year

04

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009722