UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007817
Receipt number R000009100
Scientific Title Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Date of disclosure of the study information 2012/05/14
Last modified on 2018/03/01 18:30:33

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Basic information

Public title

Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.

Acronym

Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.

Scientific Title

Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.

Scientific Title:Acronym

Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.

Region

Japan


Condition

Condition

Non-small cell lung cancer (NSCLC)

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the efficacy of detection method of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection rate of mutated EGFR from plasma

Key secondary outcomes

T790M mutation rate, Serum HGF, Progression-free survival (PFS), Toxicities


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

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Detection of mutated EGFR from plasma; gefitinib plus either S-1 or pemetrexed therapy

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) Histologically or cytologically proven non-small cell lung cancer (NSCLC)
2) Stage IIIB or IV disease
3) NSCLC with EGFR mutation (ex19 deletions or L858R)
4) NSCLC resistant to EGFR-TKI (intrinsic or acquired resistance)
5 ) Previously administered EGFR-TKI over 28 days
6) Undergoing EGFR-TKI monotherapy
7) Aged 20 years or older
8) ECOG performance status 0-2
9) One or more measurable lesions
10) No experience of either S-1 or pemetrexed
11) Experience of platinum use or considered to be ineligible for platinum-based therapy
12) Interval of at least 2 weeks from last surgical procedure or radiation therapy
13) Adequate bone marrow, renal, hepatic and cardiopulmonary function
14) Able to take oral medication
15) Life expectancy of at least 12 weeks
16) Written informed consent

Key exclusion criteria

1) Interstital pneumonitis
2) Uncontrolled intercurrent illness
3) Active infection
4) Need for treatment within 6 months for double cancer
5) Symptomatic CNS metastases
6) Massive pleural effusion or ascites
7) History of irradiation to more than half of pelvic bone
8) Allergy to treatment drugs
9) Pregnant or breast-feeding
10) Unwilling to use adequate contraception
11) Other conditions inadequate for this research

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Hosomi

Organization

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Division name

Department of Thoracic Oncology and Respiratory Medicine

Zip code


Address

3-18-22, Honkomagome, Bunkyo-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yusuke Takagi

Organization

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Division name

Department of Thoracic Oncology and Respiratory Medicine

Zip code


Address

3-18-22, Honkomagome, Bunkyo-ku, Tokyo

TEL


Homepage URL


Email



Sponsor or person

Institute

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo metropolitan government

Organization

Division

Category of Funding Organization

Local Government

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

2012 Year 05 Month 14 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/27601920

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

Terminated

Date of protocol fixation

2012 Year 04 Month 23 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 04 Month 23 Day

Last modified on

2018 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009100


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name