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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025930
Receipt No. 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

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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
Institute Division of Respiratory Medicine, Saga University Hospital
Institute
Department

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
URL(English) https://upload.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


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