UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025278
Receipt number R000027819
Scientific Title An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations.
Date of disclosure of the study information 2016/12/20
Last modified on 2021/08/05 22:48:06

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Basic information

Public title

An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations.

Acronym

An observational study of plasma EGFR mutation status during osimertinib treatment.

Scientific Title

An observational study of EGFR mutation status by circulating tumor DNA during the osimertinib treatment of lung cancer harboring EGFR activating and T790M mutations.

Scientific Title:Acronym

An observational study of plasma EGFR mutation status during osimertinib treatment.

Region

Japan


Condition

Condition

lung Cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clear the resistant mechanism of osimertinib treatment for lung cancer harboring EGFR activating and T790M mutations by periodical analysis of EGFR mutations (activating, T790M, and C797S) in circulating tumor DNA using an improved PNA-LNA PCR clamp method.

Basic objectives2

Others

Basic objectives -Others

To evaluate the percentage of the cases emerging C797S mutation in all oseimertinib resistant patients.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The occurrence ratio of plasma C797S mutations in all osimertinib resistant cases.

Key secondary outcomes

The interval between plasma C797S emerged time and the time of confirmed RECIST PD.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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 documented non-small cell lung cancer.
2. Stage IIIB or stage IV or recurrent NSCLC
3. Detected EGFR activating mutation (exon 19 deletion or exon 21 L858R) by highly sensitive PCR methods.
4. Have a history of first or second generation EGFR-TKI treatment.
5. Detected T790M mutation by highly sensitive PCR methods.
6. Regarding the patients who have be treated with radiotherapy;
1) Not have received radiotherapy to lesions of lung.
2) More than 12 weeks after receiving radiotherapy to bone metastases in thoracic lesion.
3) More than 2 weeks after receiving radiotherapy to lesions except lung.
7. Regarding the patients who have be treated with therapy as follows;
1) More than 4 weeks after the last operation
2) More than 2 weeks after the last drainage of the pleural space.
3) More than 2 weeks after the last pleurodesis except anticancer drugs
4) More than 3 weeks after the last cytotoxic chemotherapy.
8. Patients who have at least one or more measurable lesion by RESIST (Version1.1)
9. Performance status (ECOG) 0-2
10. Estimated life expectancy at least 3 months.
11. Adequate organ function for osimertinib treatment
12. Written informed consent.
13. Aged over 20 years.

Key exclusion criteria

1. Having an evidence of ILD or pulmonary fibrosis complication on chest X-ray.
2. Having a history or serious complications as bellows:
1) uncontrollable angina pectoris, cardial infarction within 3 months before enrollment, or heart failure.
2) uncontrollable diabetes or hypertension.
3) Severe infectious disease..
4) gastrointestinal dysfunction with severe diarrhea.
3. Impossible to take drugs orally.
4. Inadequate case considered from drug package insert of osimertinib.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Maemondo

Organization

Miyagi Cancer Center

Division name

Department of respiratory medicine

Zip code


Address

47-1 Nodayama, Medecshima-Shiote, Natori, Japan

TEL

022-384-3151

Email

maemondo-ma693@miyagi-pho.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuro Fukuhara

Organization

Miyagi Cancer Center

Division name

Department of respiratory medicine

Zip code


Address

47-1 Nodayama, Medecshima-Shiote, Natori, Japan

TEL

022-384-3151

Homepage URL


Email

fukuhara-tatsuro@miyagi-pho.jp


Sponsor or person

Institute

Miyagi Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Miyagi Cancer Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Division of Cancer Biology and Therapeutics, Miyagi Cancer Center Research Institute.
Molecular Genetic Research Department, LSI Medience Corporation.

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

2016 Year 12 Month 20 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

Main results already published

Date of protocol fixation

2016 Year 09 Month 25 Day

Date of IRB

2016 Year 10 Month 05 Day

Anticipated trial start date

2016 Year 10 Month 05 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To clear the resistant mechanism of osimertinib treatment for lung cancer harboring EGFR activating and T790M mutations by periodical analysis of EGFR mutations (activating, T790M, and C797S) in circulating tumor DNA using an improved PNA-LNA PCR clamp method. Analysis points are before treatment, every 8 weeks from osimertinib started, and Confirmed RECIST-PD.


Management information

Registered date

2016 Year 12 Month 15 Day

Last modified on

2021 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027819


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name