UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025930
Receipt number R000029786
Scientific Title Prospective study for usefulness of plasma DNA on prediction of third generation EGFR tyrosine kinase inhibitors
Date of disclosure of the study information 2017/02/01
Last modified on 2019/08/06 09:09:16

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Basic information

Public title

Prospective study for usefulness of plasma DNA on prediction of third generation EGFR tyrosine kinase inhibitors

Acronym

S-PLAT study

Scientific Title

Prospective study for usefulness of plasma DNA on prediction of third generation EGFR tyrosine kinase inhibitors

Scientific Title:Acronym

S-PLAT study

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The purpose of this prospective study is to determine whether treatment efficacy of osimertinib and detection of T790M in plasma DNA using MBP-QP method are correlated in non-small lung cancer patients who acquired resistance to 1st and 2nd generation of EGFR-TKI.

Basic objectives2

Others

Basic objectives -Others

The study is to determine the usefulness of T790M detection using the assay system on prediction of treatment.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison of overall response rate between T790M positive by MBP-QP using plasma DNA and by cobas is performed.

Key secondary outcomes

Comparison of progression free survival between T790M positive by MBP-QP using plasma DNA and by cobas is performed.


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. Non-small cell lung cancer patients with EGFR activating mutations such as G719X, exon 19 deletion, L858R and L861Q.
2. Non-small cell lung cancer patients with lesions which can be evaluated by RECIST (Version 1.1).
3. Non-small cell lung cancer patients who acquired resistance to EGFR-TKI.
4. Patient is at least 20 years of age (at enrollment date).
5. Patients with non-small-cell lung cancer (NSCLC) confirmed histologically or cytologically.
6. Performance status (ECOG): 0-2
7. Non-small cell lung cancer patients with written consent.

Key exclusion criteria

1. The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) does not meet the following all standard.
1.WBC count >= 3,000/mm3
2.Haemoglobin >= 9.0g/dL
3.Platelet count >=100,000/mm3
4.AST, ALT <=100 IU/L
5.Total bilirubin <=1.5mg/dL
6.Creatinine<=1.5mg/dL
7.SpO2 >= 90%
10) Corrected QT interval (QTc) <= 470 msec.
2. Any cytotoxic chemotherapy within 14 days of the first dose of study treatment.
3. Radiotherapy within 4 weeks of the first dose of study treatment.
4. Previously treated with osimertinib.
5. Previously treated with immune checkpoint inhibitors.
6. Patients currently receiving medications to be potent inhibitors of CYP2C8 and potent inhibitors or inducers of CYP3A4.
7. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy.
8. Brain metastases with symptoms.
9. Any evidence of severe or uncontrolled systemic diseases, including severe cardiac diseases, severe, cerebrovascular diseases, uncontrolled diabetes mellitus, hypertension, severe infection, pneumonitis, respiratory failure, active bleeding active GI bleeding, severe neurological diseases, QTc prolongation (Corrected QT interval (QTc) >470 msec)
10. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
11. HBs antigen-positive
12. Active double cancer
13. Pregnant or possibly pregnant women, lactating women, or patients who wish to become pregnant
14. Patients who, in the opinion of the attending physician, are inappropriate for the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoko Aragane

Organization

Saga University Hospital

Division name

Division of Respiratory Medicine

Zip code


Address

5-1-1 Nabeshima, Saga, 849-8501

TEL

0952-34-2369

Email

sueokan@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chiho Nakashima

Organization

Saga University Hospital

Division name

Division of Respiratory Medicine

Zip code


Address

5-1-1 Nabeshima, Saga, 849-8501

TEL

0952-34-2369

Homepage URL


Email

15624019@edu.cc.saga-u.ac.jp


Sponsor or person

Institute

Division of Respiratory Medicine, Saga University Hospital

Institute

Department

Personal name



Funding Source

Organization

AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

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

2017 Year 02 Month 01 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

57

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

No longer recruiting

Date of protocol fixation

2017 Year 01 Month 26 Day

Date of IRB

2017 Year 01 Month 12 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2021 Year 01 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Exploratory objectives
1. Investigation of association between treatment efficacy such as ORR, PFS of osimertinib and the fraction of T790M using liquid biopsy.
2. Investigation of mutation analysis such as T790M, C797S, BRAF V600E using MBP-QP method after acquired resistance to osimertinib. In addition, novel mutations will be analyzed using NGS.
3. Investigation of concordance rate of T790M using between MBP-QP method and cobas EGFR Mutation Test v. 2.


Management information

Registered date

2017 Year 01 Month 31 Day

Last modified on

2019 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029786


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name