UMIN-CTR Clinical Trial

Public title

Phase II study of erlotinib in advanced or recurrent EGFR mutation positive Non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion.

Acronym

Phase II study of erlotinib in advanced or recurrent EGFR mutation positive NSCLC patients who were previously treated with intrapleural therapy for malignant pleural effusion.

Scientific Title

Phase II study of erlotinib in advanced or recurrent EGFR mutation positive Non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion.

Scientific Title:Acronym

Phase II study of erlotinib in advanced or recurrent EGFR mutation positive NSCLC patients who were previously treated with intrapleural therapy for malignant pleural effusion.

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 of erlotinib in advanced or recurrent EGFR mutation positive non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Disease control rate, Progression free survival, Overall survival, Adverse events, 4-weeks pleural effusion progression free survival rate, Pleural effusion progression free suvival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1,Cytologically or histologically proven non-small cell lung cancer
2)Cytologically or histologically proven malignant pleural effusion associated with non-small cell lung cancer
3,Clinical stage IV or post-operative recurrence
4,Prior tube thoracostomy followed by intrapleural therapy for malignant pleural effusion
5,EGFR mutation positive
6,No prior EGFR tyrosine kinase inhibitor treatment
7,ECOG Performance status 0-3 after tube thoracostomy
8,Adequate organ functions
9,Mesurable lesions (RECIST)
10,Adequate interval after prior treatments; 2 weeks from OK-432, Talc, 6 weeks from Mitomycin
11,Written informed consent

Key exclusion criteria

1,Massive pericardial effusion or ascites
2,Severe drug allergy
3,Active infection
4,Continuous watery diarrhea
5,Intestinal paralysis or ileus
6,Interstitial pneumonia or lung fibrosis evident on CT
7,Symptomatic ophthalmologic disease
8,Current or previous (within the last 1 year) history of GI perforation
9,Serious non—healing ulcer
10,Symptomatic or steroid-requiring brain metastases
11,Active concomitant malignancy
12,Previous (within the last 5 years) concomitant malignancy
13,Uncontrolled diabetes
14,Severe cardiac disease
15,Severe psychological disease
16,Pregnant or lactating women or those who declined contraception
17,Those judged to be not suitable by the attending physician

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Noriyuki Masuda

Organization

Kitasato university hospital

Division name

Department of respiratory medicine

Zip code

Address

1-15-1, Kitasato, Sagamihara, Kanagawa, 252-0375

TEL

Email

Name of contact person

1st name
Middle name
Last name	Michiko Yamamoto

Organization

Kitasato university hospital

Division name

Department of respiratory medicine

Zip code

Address

1-15-1, Kitasato, Sagamihara, Kanagawa, 252-0375

TEL

Homepage URL

Email

Institute

Kitasato university hospital

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

2011

Year

10

Month

12

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

Open public recruiting

Date of protocol fixation

2011

Year

01

Month

11

Day

Date of IRB

Anticipated trial start date

2011

Year

02

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

2011

Year

10

Month

11

Day

Last modified on

2011

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007731