UMIN-CTR Clinical Trial

Public title

Multicenter Phase II study of erlotinib
for advanced or recurrent non-small cell lung cancer with Epidermal Growth factor Receptor (EGFR) mutation (TORG0911)

Acronym

Phase II Study of low dose erlotinib in EGFR mutation Non-Small Cell Lung Cancer(TORG0911)

Scientific Title

Multicenter Phase II study of erlotinib
for advanced or recurrent non-small cell lung cancer with Epidermal Growth factor Receptor (EGFR) mutation (TORG0911)

Scientific Title:Acronym

Phase II Study of low dose erlotinib in EGFR mutation Non-Small Cell Lung Cancer(TORG0911)

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To investigate efficacy and safety of low dose erlotinib for advanced or recurrent Non-small cell lung cancer with EGFR mutation

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Disease control rate, response rate in patients who have stable disease after dose escalation , progression free survival, overall survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Erlotinib treatment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)patients with pathologically proven non-small cell lung cancer
2)patients with stage IIIB or IV who are not candidates for curative radiotherapy
3)patients with prior chemotherapy regimens three or less
4)patients having EGFR mutation (exon 18, exon 19 or Exon 21)
5)no prior treatment with EGFR
tyrosine kinase inhibitor
6)possible cases with oral
administration
7)performance status (ECOG)0-2
8)patient who has measurable lesions by RECIST
9)close and meticulous clinical observation with (or without)
hospitalization during the first four
weeks of treatment
10)patients aged 20 years or older
11)sufficient function of main organ and bone marrow
12)more than 4 weeks after the last chemotherapy
13)signed informed consent

Key exclusion criteria

1)previous radiotherapy to primary lung cancer
2)superior vena caval syndrome
3)severe drug allergy
4)large peritoneal or pericardial
effusion
5)active infection
6)continuous watery diarrhea
7)intestinal paralysis or ileus
8)interstitial pneumonia or lung
fibrosis evident on CT
9)symptomatic ophthalmologic disease
10)current or previous (within the last 1 year) history of GI perforation
11)serious non-healing ulcer
12)Symptomatic or steroid-requiring brain metastases
13),14)active concomitant malignancy
15)uncontrolled diabetes
16)severe cardiac disease
17)severe psychological disease
18)pregnant or lactating women or those who declined contraception
19)those judged to be not suitable by the attending physician

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Hideo Kunitoh

Organization

Japanese Red Cross Medical Center

Division name

Division of Chemotherapy Department of Internal Medicine

Zip code

Address

4-1-22 Hiroo, Shibuya-ku, Tokyo

TEL

03-3400-1311

Email

kunito_hideo@med.jrc.or.jp

Name of contact person

1st name
Middle name
Last name	Hideo Kunitoh

Organization

Japanese Red Cross Medical Center

Division name

Division of Chemotherapy Department of Internal Medicine

Zip code

Address

4-1-22 Hiroo, Shibuya-ku, Tokyo

TEL

03-3400-1311

Homepage URL

http://www.torg.or.jp/

Email

kunito_hideo@med.jrc.or.jp

Institute

Thoracic Oncology Research Group

Institute

Department

Personal name

Organization

Thoracic Oncology Research Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

2010

Year

03

Month

14

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/26174465

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

Completed

Date of protocol fixation

2010

Year

02

Month

23

Day

Date of IRB

Anticipated trial start date

2010

Year

03

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

2010

Year

03

Month

11

Day

Last modified on

2019

Year

02

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003989