UMIN-CTR Clinical Trial

Public title

A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutation

Acronym

A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer with EGFR Mutation

Scientific Title

A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutation

Scientific Title:Acronym

A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer with EGFR Mutation

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To investigate efficacy and safety of Erlotinib for previously treated Non-small cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

rseponse rate

Key secondary outcomes

Disease control rate, Progression free survival, overall survival, Median survival time, 1-year survival rate, Evaluation of 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 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with pathologically proven non-small cell lung cancer.
2) Patients with stage IIIB or IV who are not candidates for curative radiotherapy.
3) Patients having EGFR mutation (exon 19 deletion or L858R) by PNA-LNA PCR clamp method.
4) No prior treatment with medicine concerning HER(gefitinib, trastuzumab, lapatinib, cetuximab,etc.).
5) Patients who have previously treated one or two chemotherapy(prior chemotherapy consisting of platinum agents in at least one regimen).
6) Patient who has at least one or more measurable lesion by RECIST.
7) ECOG performance status (PS): 0-2
8) Patients who can be hospitalized for four weeks after beginning of the treatment or under management to apply to it.
9) Patients aged 20 years or older.
10) Adequate organ function.
11) Patients who are considered to survive for more than 3 months.
12) Written informed consent.

Key exclusion criteria

1) Active infection or other serious disease condition (poorly controlled diabetes mellitus,cardiac disease, Unstable angina, Cardiac infarction, Psychological illness, etc.).
2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome.
4) Symptomatic brain metastasis.
5) Severe drug allergy.
6) Previous radiotherapy to primary lung cancer.
7) Patients who have previously treated three or more chemotherapy.
8) Patients who had a relapse after surgery.
9) With active double cancer.
10) Pregnancy or lactation.
11) Severe disorder of the eye.
12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Target sample size

29

Name of lead principal investigator

1st name
Middle name
Last name	Yoshinori Hasegawa

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code

Address

65 Tsurumai-cho, Showo-ku, Nagoya-City, Aichi, 466-8550, Japan

TEL

052-744-2167

Email

yhasega@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Masashi Kondo, Masahiro Morise, Tetsunari Hase

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code

Address

65 Tsurumai-cho, Showo-ku, Nagoya-City, Aichi, 466-8550, Japan

TEL

052-744-2167

Homepage URL

http://cjlsg.umin.jp/index.html

Email

cjlsg@med.nagoya-u.ac.jp

Institute

Central Japan Lung Study Group (CJLSG)

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

2009

Year

11

Month

06

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

No longer recruiting

Date of protocol fixation

2009

Year

09

Month

20

Day

Date of IRB

Anticipated trial start date

2009

Year

11

Month

01

Day

Last follow-up date

2012

Year

11

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

11

Month

05

Day

Last modified on

2014

Year

11

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003311