UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002795
Receipt number R000003398
Scientific Title Phase II study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR(NEJ006/TCOG0903)
Date of disclosure of the study information 2009/11/25
Last modified on 2012/11/28 14:24:28

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Basic information

Public title

Phase II study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR(NEJ006/TCOG0903)

Acronym

Erlotonib in pre-treated NSCLC with wild type EGFR

Scientific Title

Phase II study of erlotinib in previously treated non-small cell lung cancer (NSCLC) with wild type EGFR(NEJ006/TCOG0903)

Scientific Title:Acronym

Erlotonib in pre-treated NSCLC with wild type EGFR

Region

Japan


Condition

Condition

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

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Disease control rate, progression free survival, overall survival, and safety. The biomarkers that predict the efficacy will be searched.


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

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



Eligibility

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)Stage IIIB, IV disease, or relapsed diseases after surgery that lack indication of surgery or radiotherapy
3)A tumor specimen is available
4)Wild type EGFR
5)Measureable region evaluable according to the RECIST
6)Number of previous chemotherapy regimens are 1 or 2
7)No previous EGFR-TKI treatment
8)Never or light smoker less than 10 pack year
9)Elder than 20 years of age
10)ECOG performance status of 0-2
11)Expected to be observed for at least 2 weeks in a hospital or in a comparable institution after the initiation of erlotinib treatment
12)Adequate organ functions (WBC => 3,000 /mm3, Neutrophil =>1,000 /mm3, Platelet => 100,000 /mm3, hemoglobin concentration => 9.0 g/dl, AST or ALT <= ULN x 2, Total bilirubin <= 1.5 mg/dl, Cr <= 1.5 mg/dl, SpO2 => 95%)
13)Life expectancy of at least 3 months
14)Sufficient time has elapsed after the previous treatment
(1)More than 3 weeks after last day of chemotherapy
(2)More than 12 weeks after thoracic radiation
(3)More than 2 weeks after surgical treatment
15)Written informed consent

Key exclusion criteria

1)Presence of active interstitial pneumonia, radiation pneumonia, pneumoconiosis, or drug induced pneumonia
2)Uncontrolled pleural effusion, ascites, or pericardial effusion
3)Presence of infection that necessitates treatments with intravenous antibiotics
4)History of HER-related drug treatment
5)T790M mutation
6)Symptomatic eye disease
7)Pregnant patients
8)Symptomatic brain metastases
9)Other active malignancies
10)Poorly controlled diabetes mellitus
11)Severe and uncontrolled complication
12)Current smoker
13)Evaluated to be ineligible by a physician for other reasons

Target sample size

43


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Saijo

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Medical Oncology

Zip code


Address

Zaifumachi 5, Hirosaki, 036-8562, Japan

TEL

81-172-39-5345

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasuo Saijo

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Medical Oncology

Zip code


Address

Zaifumachi 5, Hirosaki, 036-8562, Japan

TEL

81-172-39-5345

Homepage URL


Email

yasosj@cc.hirosaki-u.ac.jp


Sponsor or person

Institute

North East Japan Study Group /The Tokyo
Cooperative Oncology Group

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2009 Year 11 Month 25 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2009 Year 11 Month 04 Day

Date of IRB


Anticipated trial start date

2009 Year 11 Month 01 Day

Last follow-up date

2012 Year 04 Month 01 Day

Date of closure to data entry

2013 Year 01 Month 31 Day

Date trial data considered complete

2013 Year 02 Month 28 Day

Date analysis concluded

2013 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2009 Year 11 Month 24 Day

Last modified on

2012 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003398


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name