UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011472
Receipt number R000013426
Scientific Title Phase II study of erlotinib monotherapy for elderly patients with untreated advanced non-small cell lung cancer, 75 years-old or older, and positive EGFR mutation status (OSAKA-LCSG1303)
Date of disclosure of the study information 2013/08/27
Last modified on 2015/06/30 15:13:48

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II study of erlotinib monotherapy for elderly patients with untreated advanced non-small cell lung cancer, 75 years-old or older, and positive EGFR mutation status (OSAKA-LCSG1303)

Acronym

OSAKA-LCSG1303

Scientific Title

Phase II study of erlotinib monotherapy for elderly patients with untreated advanced non-small cell lung cancer, 75 years-old or older, and positive EGFR mutation status (OSAKA-LCSG1303)

Scientific Title:Acronym

OSAKA-LCSG1303

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of erlotinib monotherapy for elderly patients with untreated advanced non-small cell lung cancer, 75 years-old or older, and positive EGFR mutation status

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression Free Survival : PFS

Key secondary outcomes

Response Rate(RR), 1 year survival rate, Frequency and grade of adverse event, QOL assessment(EORTC QLQ-C30, EORTC QLQ-LC13)


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

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)75 years-old or older
(2) Histologically or cytologically confirmed non-small cell lung cancer
(3) Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery, or recurrence 6 months after postoperative adjuvant chemotherapy
(4) With positive EGFR mutation status (deletion of exon 19 or L858R point mutation in exon 21), and without T790M point mutation status in exon 20
(5) ECOG performance status of 0 to 2
(6) Evaluable disease (RECIST ver1.1)
(7) No history of EGFR-TKI
(8) Adequate organ function, evaluated within 14 days before enrollment as;
ALT <or= 100IU/L
Total bilirubin <or=2.0mg/dL
(9) Interval; 3 weeks after immunotherapy or hormone therapy, 2 weeks after pleurodesis with anti-tumor agent
(10) Written informed consent

Key exclusion criteria

(1)Problematic infection that requires anti-biotic, anti-fungal agent or anti-viral agent
(2)Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest CT or with clinical symptoms
(3) A history of severe hypersensitivity against erlotinib
(4) Difficulty in oral administration of erlotinib, functional / organic impairment or inflammatory bowel disease that disturbs absorption of erlotinib
(5) Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer
(6) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
(7) Psychologically ineligible
(8) Decision of ineligibility by a physician

Target sample size

31


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seigo Minami

Organization

Osaka Police Hospital

Division name

Dept. of Respiratory Medicine

Zip code


Address

10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan

TEL

06-6771-6051

Email



Public contact

Name of contact person

1st name
Middle name
Last name Seigo Minami

Organization

Osaka Police Hospital

Division name

Dept. of Respiratory Medicine

Zip code


Address

10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan

TEL

06-6771-6051

Homepage URL


Email



Sponsor or person

Institute

OSAKA-LCSG

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

大阪警察病院(大阪府)、大阪大学医学部付属病院(大阪府)、市立豊中病院(大阪府)、大阪府済生会千里病院(大阪府)、大阪府立急性期総合医療センター(大阪府)、大阪府立呼吸器・アレルギー医療センター(大阪府)、大阪府立成人病センター(大阪府)、国立病院機構 近畿中央胸部疾患センター(大阪府)、公立学校共済組合 近畿中央病院(兵庫県)、国立病院機構 刀根山病院(大阪府)、西宮市立中央病院(兵庫県)、日本生命済生会 日生病院(大阪府)、国立病院機構 大阪南医療センター(大阪府)、関西医科大学附属枚方病院(大阪府)、関西医科大学附属滝井病院(大阪府)、箕面市立病院(大阪府)、市立吹田市民病院(大阪府)


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 27 Day


Related information

URL releasing protocol


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

Terminated

Date of protocol fixation

2013 Year 08 Month 13 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 08 Month 13 Day

Last modified on

2015 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013426


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name