UMIN-CTR Clinical Trial

Public title

PhaseII study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR

Acronym

Erlotonib in pre-treated NSCLC with wild type EGFR

Scientific Title

PhaseII study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR

Scientific Title:Acronym

Erlotonib in pre-treated NSCLC with wild type EGFR

Region

Japan

Condition

Pre-treated non-small cell lung cancer with wild type EGFR and occurred in never or light smoker

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of erlotinib monotherapy for previously treated non-small cell lung cancer (NSCLC) harboring wild type EGFR and occurred in never or light smoker

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response rat

Key secondary outcomes

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

Daily administration of erlotinib

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) Histologically or cytologically proved NSCLC
2) StageIIIB and IV disease or relapsed diseases after surgery that lack indication of surgery or radiotherapy
3) Patients who have previously treated 1 or 2 regimens of chemotherapy
*Prior chemotherapy consisting of platinum agents in at least one regimen
4) Wild type EGFR
5) No previous EGFR-TKI treatment
6) Never or light smoker less than 10 pack year
7) possible to treat by the oral preparation
8) ECOG performance status of 0-2
9) Measureable region evaluable according to the RECIST
10) Expected to be observed for at least 2-4 weeks in a hospital or in a comparable institution after the initiation of erlotinib treatment
11) Elder than 20 years of age
12) Adequate organ functions
1.WBC -> 3,000 /mm3
2.Neutrophil ->1,500 /mm3
3.Platelet -> 100,000 /mm3
4.Hemoglobin concentration -> 9.0 g/dl
5.AST or ALT <- ULN x 2.5
6.Total bilirubin <- 1.5 mg/dl
7.Cr <- 1.5 mg/dl
8.SpO2 -> 95%
13) More than 4 weeks after last day of previous treatment
14) Written informed consent after the explanation of the content of the examination

Key exclusion criteria

1) Radiotherapy to the primary site which is only possible to evaluate
2) superior vena cava syndrome
3) History of severe drug allergy
4) Uncontrolled pleural effusion, ascites, or pericardial effusion
5) History of active infection
6) Uncontrollable diarrhea
7) History of ileus
8) Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
9) Symptomatic eye disease
10) Current or previous(within the last 1 year) history of GI perforation
11) uncontrollable ulcer
12) Symptomatic brain metastases
13) Other active malignancies
14) History of active double cancer
15) Poorly controlled diabetes mellitus
16) History of severe heart disease
17) History of active psychological disease
18) History of pregnancy or lactation
19) Evaluated to be ineligible by a physician for other reasons

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Iwamoto

Organization

Hiroshima citizens hospital

Division name

Department of Medical Oncology

Zip code

Address

7-35 Motomachi , Naka-ku, Hiroshima, 730-8518, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Hiroshima citizens hospital

Division name

Department of Medical Oncology

Zip code

Address

TEL

Homepage URL

Email

Institute

Hiroshima citizens hospital
Department of Medical Oncology

Institute

Department

Personal name

Organization

None

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

2011

Year

04

Month

22

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

2009

Year

10

Month

20

Day

Date of IRB

Anticipated trial start date

2010

Year

01

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

2011

Year

04

Month

22

Day

Last modified on

2013

Year

01

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006516