UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001509
Receipt number R000001821
Scientific Title Phase II study of erlotinib monotherapy for relapsed patients with non-small-cell lung cancer who do not possess any active EGFR gene mutations
Date of disclosure of the study information 2008/11/16
Last modified on 2009/05/16 09:27:36

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II study of erlotinib monotherapy for relapsed patients with non-small-cell lung cancer who do not possess any active EGFR gene mutations

Acronym

Erlotinib for relapsed non-small-cell lung cancer patients without any
active EGFR gene mutations

Scientific Title

Phase II study of erlotinib monotherapy for relapsed patients with non-small-cell lung cancer who do not possess any active EGFR gene mutations

Scientific Title:Acronym

Erlotinib for relapsed non-small-cell lung cancer patients without any
active EGFR gene mutations

Region

Japan


Condition

Condition

relapsed non-small-cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The objective of this study is to evaluate antitumor response as the primary endpoint of erlotinib monotherapy for relapsed patients with non-small-cell lung cancer who do not possess any active EGFR gene mutations

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Anti-tumor activity

Key secondary outcomes

Adverse events, overall survival, progression-free survival, questionnaire about participation in this study, and molecular analysis using tumor samples (MET gene amplification, PTEN expression, K-ras gene mutation, methylation anlaysis for serum MGMT, RARB, p16, DAPK, RASSF1A, and EGFR)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Single agent chemotherapy with 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



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Pathologically proven NSCLC
Patients with targeted lesions defined in the RECIST guideline
Patients previously treated with 1 to 3 chemotherapy regimens
Those without any active EGFR mutations in the tumor specimens
Those with no prior therapy within four weeks
Those with ECOG PS of 0 to 2
Those considered to survive for more than two months
Those with adequate organ functions
Those providing written informed consent

Key exclusion criteria

Patients without adequate tumor samples for assessing EGFR mutation status
Those with severe co-morbidity including uncontrollable cardiac, cerebral and infectious disease and diabetes mellitus
Those with symptomatic cerebral metastasis
Those with active interstitial pneumonia or massive malignant pleural/pericardial effusion
Pregnant or lactating women
Those previously treated with EGFR-tyrosine kinase inhibitors
Those who need to be treated immediately with radiotherapy
Patients judged as being in inappropriate condition for this study by physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsune Tanimoto

Organization

Okayama University Hospital

Division name

Hematology, Oncology, Respiratory Medicine

Zip code


Address

2-5-1 Shikata-cho, Okayama 700-8558

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Okayama Lung Cancer Study Group Coordinating Office

Division name

Hematology, Oncology, Respiratory Medicine

Zip code


Address


TEL

086-235-7227

Homepage URL


Email



Sponsor or person

Institute

Okayama Lung Cancer Study Group

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

2008 Year 11 Month 16 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

Completed

Date of protocol fixation

2008 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2008 Year 01 Month 01 Day

Last follow-up date

2009 Year 11 Month 01 Day

Date of closure to data entry

2009 Year 12 Month 01 Day

Date trial data considered complete

2009 Year 12 Month 01 Day

Date analysis concluded

2009 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 11 Month 16 Day

Last modified on

2009 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001821


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name