UMIN-CTR Clinical Trial

Public title

A phase II study of Erlotinib for patients previously treated non-small cell lung cancer with epidermal growth factor receptor mutation

Acronym

A phase II study of Erlotinib for patients previously treated non-small cell lung cancer with epidermal growth factor receptor mutation

Scientific Title

A phase II study of Erlotinib for patients previously treated non-small cell lung cancer with epidermal growth factor receptor mutation

Scientific Title:Acronym

A phase II study of Erlotinib for patients previously treated non-small cell lung cancer with epidermal growth factor receptor mutation

Region

Japan

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate efficacy and safety in patients previously treated non-small cell lung cancer with epidermal growth factor receptor mutation (Exon19, Exon21)

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

desease control rate, progression-free survival, overall survival, safety

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 150mg/day, oral daily

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)Patients with StageIIIB or IV who pathologically proven non-small cell lung cancer.
2)Patients who have previously treated with one or two chemotherapy.
3)No prior treatment with EGFR-TKI(erlotinib,gefitinib,ZD6474,etc.).
4)Patients with EGFR mutation(Exon19,Exon21).
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.
*Leukocyte counts >= 3,000/mm3
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0 g/dl
*AST and ALT, x 2 of upper limit of normal (ULN) or less.
*Total bilirubin, 1.5mg/dl or less.
*Serum creatinin, x 1.5 of ULN or less.
*SpO2 90% or above.
12)interval:
(1)chemotherapy, more than 4 weeks after the last chemotherapy.
(2)Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs.
(3)Operation, more than 4 weeks after the last operation (including pleurodesis)
13)Patients providing 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
5)Impossible cases with oral administration
6)Patients with active opthalmological disease
7)Patients with current or previous (within one year) history of gastrointestinal perforation
8)Patients with uncontrollable gastrointestinal ulceration
9)Pregnancy or lactation
10)Patients with symptomatic brain metastasis
11)Patients with active concomitant malignancy
12)Patients with uncontrollable diabetes mellitus
13)Patients with uncontrollable complications
14)Inappropriate patients for this study judged by the physicians

Target sample size

26

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Ishida

Organization

Fukushima medical University

Division name

cancer center

Zip code

Address

Hikarigaoka 1, Fukushima city

TEL

024-547-1111

Email

poroishida@gmail.com

Name of contact person

1st name
Middle name
Last name	Takashi Ishida

Organization

Fukushima Medical University, School of Medicine

Division name

Pulmonary Medicine

Zip code

Address

Hikarigaoka 1, Fukushima city

TEL

024-547-1111

Homepage URL

Email

poroishida@gmail.com

Institute

Fukushima Medical University, cancer center

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

2010

Year

11

Month

15

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

08

Month

10

Day

Date of IRB

Anticipated trial start date

2010

Year

03

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

2010

Year

11

Month

15

Day

Last modified on

2018

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005452