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

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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

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

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

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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