UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011986
Receipt number R000014007
Scientific Title A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
Date of disclosure of the study information 2013/10/08
Last modified on 2013/10/08 02:41:35

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Basic information

Public title

A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer

Acronym

A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer

Scientific Title

A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer

Scientific Title:Acronym

A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer

Region

Japan


Condition

Condition

non-squamous non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluate efficacy and safety of erlotinib therapy for 3/4
Stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Disease Control Rate, Progression-free survival, Overall survival, Surgery rate, Pathological Complete Response Rate, Complete resection rate, Safety, Biomarker


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 150mg/day

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)stage III/IV non-squamous non-small cell lung cancer
2) EGFR gene mutation positive
3) Prior treatment of chemoradiotherapy or chemotherapy for non-small cell lung cancer patients for up to 1 regimen in the EGFR-TKI untreated
4)20 years or older
5)PS:0-2 (ECOG)
6)at least one measurable leision (RECIST)
7)patients who has the following periods
*the last prior chemotherapy:3weeks
*whole-brain irradiation(WBRT):2weeks
*stereotactic irradiation(SRI):1day
*irradiation of bone metastases:1day
*palliative radiotherapy:2weeks
*operation(surgery without lobectomy):4weeks
*operation(endoscopic surgery without lobectomy):2weeks
*biopsy with incision, port custody, and treatment to injury:1week
*pleurodesis:2weeks
*chest drainage:1weeks
8)adequate bone marrow,liver,and renal functions
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0g/dL
*AST and ALT, x 2.5 of upper limit of
normal (ULN) or less
*Total bilirubin <= 1.5mg/dL
*Serum creatinin, x 1.5mg/dL of ULN or less
*SpO2(Room air) >=90%
* PT-INR < 1.5
*Protein urea <= 1+
9)a life expectancy of 3 months or more
10)written informed consent

Key exclusion criteria

1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
2)known EGFR-TKI resistance gene mutation(T790M) positive
3)history of erlotinib or gefitinib treatment
4)inable of oral drug administration
5)history of myocardial infarction and cerebral infarction within one year
6)planned surgery within study term
7)history of drug allergy
8)massive,pleural effusion or ascites
9)uncontrolled infection or serious medical complications
10)active concomitant malignancy
11)mental disorder
12)pregnant or or lactating women or those who declined contraception
13)those judged not suitable by the attending physician

Target sample size

21


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshinari Ema

Organization

Itabashi central medical center

Division name

Department of Thoracic Surgery

Zip code


Address

2-12-7 Azusawa, Itabashi, Tokyo 174-0051

TEL

03-3967-0572

Email

toshinariema09@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshinari Ema

Organization

Itabashi central medical center

Division name

Department of Thoracic Surgery

Zip code


Address

2-12-7 Azusawa, Itabashi, Tokyo 174-0051

TEL

03-3967-0572

Homepage URL


Email

toshinariema09@yahoo.co.jp


Sponsor or person

Institute

Itabashi central medical center

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



Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 08 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

Preinitiation

Date of protocol fixation

2013 Year 07 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 31 Day

Last follow-up date

2016 Year 07 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 08 Day

Last modified on

2013 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014007


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name