UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003270
Receipt number R000003950
Scientific Title Multicenter Phase II study of erlotinib therapy in recurrent or advanced non-small cell lung cancer patients with Epidermal Growth Factor Receptor (EGFR) mutation
Date of disclosure of the study information 2010/03/01
Last modified on 2016/07/26 13:38:14

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Basic information

Public title

Multicenter Phase II study of erlotinib therapy in recurrent or advanced non-small cell lung cancer patients with Epidermal Growth Factor Receptor (EGFR) mutation

Acronym

Phase II Study of erlotinib in EGFR mutation Non-Small Cell Lung Cancer.

Scientific Title

Multicenter Phase II study of erlotinib therapy in recurrent or advanced non-small cell lung cancer patients with Epidermal Growth Factor Receptor (EGFR) mutation

Scientific Title:Acronym

Phase II Study of erlotinib in EGFR mutation Non-Small Cell Lung Cancer.

Region

Japan


Condition

Condition

Non small cell lung cancer with Epidermal Growth Factor Receptor mutation

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the efficacy and safety of erlotinib in advanced or recurrent NSCLC with EGFR mutation in Exon 19 and 21.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response Rate

Key secondary outcomes

Disease Contorol Rate,Safety,Progression Free Survival,Overall Survival


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

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven stage IIIb or IV non-small cell lung cancer.
2) Patients who have previously treated one or two chemotherapy.
3) No previous treatment with EGFR-TKI
4) Patients having EGFR mutation (exon 19 deletion or L858R)
5)Possible cases with oral administration.
6) Patient who has at least one or more measurable lesion by RECIST.
7)Performance status (ECOG)0-2.
8) Patients who can be hospitalized for two weeks after beginning of the treatment or under management to apply to it.
9) Patients aged 20 years or older.
10) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment:
*Leukocyte counts, 3,000/mm3 or over -12,000/mm3 or less.
*Neutrophil counts, 1,500/mm3 or over -5000/mm3 or less.
*Platelets, 100,000/mm3 or over.
*Hemoglobin, 9.0g/dL or over.
*AST and ALT, x 2 of upper limit of normal (ULN) or less.
*Serum bilirubin, 1.5mg/dl or less.
*Serum creatinin, x 1.5 of ULN or less.
*SpO2 90% or above(room air).
11) Patients who are considered to survive for more than 3 months.
12) Interval
(1)Chemotherapy: more than 4weeks after the last chemotherapy
(2)Radiation: more than 12weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs
(3)Operation: more than 4weeks after the last operation(including pleurodesis)
13)Written informed consent.

Key exclusion criteria

1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis.
2)Patients with massive pleural or pericardial effusion ,or ascites.
3)Patients with active severe infections.
4)Cases with past history of administration of HER related agents.
[ex) gefitinib, lapatinib, trsutuzumab, cetuximab]
5)Impossible cases with oral administration.
6)Patients with active opthalmological disease.
7) Patients with active concomitant malignancy.
8) Patients with symptomatic brain metastasis.
9)Patients with double cancer.
10)Patients with uncontrollabe diabetes mellitus.
11)Patients with uncontrollable complications.
12)Inappropriate patients for this study judged by the physicians.

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoichi Nakanishi

Organization

Kyushu University, Graduate School of Medical Sciences

Division name

Research Institute for Diseases of the Chest

Zip code


Address

3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582

TEL

092-642-5378

Email

yoichi@kokyu.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Takayama

Organization

Kyushu University, Graduate School of Medical Sciences

Division name

Research Institute for Diseases of the Chest

Zip code


Address

3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582

TEL

092-642-5378

Homepage URL


Email

koichi-t@kokyu.med.kyushu-u.ac.jp


Sponsor or person

Institute

Lung Oncology Group in Kyushu, Japan (LOGIK)

Institute

Department

Personal name



Funding Source

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

九州大学病院(福岡県)
浜の町病院(福岡県)
福岡大学(福岡県)
国立病院機構 福岡東医療センター(福岡県)
済生会福岡総合病院(福岡県)
国立病院機構 九州医療センター(福岡県)
公立学校共済組合 九州中央病院(福岡県)
国立病院機構 福岡病院 (福岡県)
飯塚病院(福岡県)
産業医科大学病院(福岡県)
国立病院機構 大牟田病院(福岡県)
九州厚生年金病院(福岡県)
福岡大学 筑紫病院(福岡県)
北九州市立医療センター(福岡県)
久留米大学(福岡県)
大分大学(大分県)
大分県立病院(大分県)
アルメイダ病院(大分県)
国立病院機構 大分医療センター(大分県)
佐賀大学(佐賀県)
長崎大学(長崎県)
健康保険諫早総合病院(長崎県)
春回会 井上病院(長崎県)
熊本大学
熊本地域医療センター(熊本県)
国立病院機構 熊本再春荘病院(熊本県)
熊本赤十字病院(熊本県)
国立病院機構 熊本医療センター(熊本県)
宮崎大学(宮崎県)
鹿児島大学(鹿児島県)
国立病院機構 南九州病院(鹿児島県)
川内医師会立市民病院(鹿児島県)
鹿児島厚生連病院(鹿児島県)
浦添総合病院(沖縄県)
琉球大学(沖縄県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
国立病院機構 沖縄病院(沖縄県)
松山赤十字病院(愛媛県)


Other administrative information

Date of disclosure of the study information

2010 Year 03 Month 01 Day


Related information

URL releasing protocol

http://www.logik.jp/

Publication of results

Unpublished


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 02 Month 20 Day

Date of IRB


Anticipated trial start date

2009 Year 05 Month 01 Day

Last follow-up date

2012 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 03 Month 01 Day

Last modified on

2016 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003950


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name