UMIN-CTR Clinical Trial

Public title

Phase II study of erlotinib monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status (OSAKA-LCSG1304)

Acronym

OSAKA-LCSG1304

Scientific Title

Phase II study of erlotinib monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status (OSAKA-LCSG1304)

Scientific Title:Acronym

OSAKA-LCSG1304

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of erlotinib monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Overall Survival (OS)

Key secondary outcomes

Progression Free Survival (PFS), Response Rate (RR), Frequency and grade of adverse event, QOL(EORTC QLQ-PAL15)

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

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) 20 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 3 to 4
(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

23

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

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

Institute

OSAKA-LCSG

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

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）

Date of disclosure of the study information

2013

Year

08

Month

27

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

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 related 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=R000013428