UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000029786