Unique ID issued by UMIN | UMIN000025930 |
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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 |
Prospective study for usefulness of plasma DNA on prediction of third generation EGFR tyrosine kinase inhibitors
S-PLAT study
Prospective study for usefulness of plasma DNA on prediction of third generation EGFR tyrosine kinase inhibitors
S-PLAT study
Japan |
Non-small cell lung cancer
Pneumology | Chest surgery |
Malignancy
YES
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.
Others
The study is to determine the usefulness of T790M detection using the assay system on prediction of treatment.
Exploratory
Not applicable
Comparison of overall response rate between T790M positive by MBP-QP using plasma DNA and by cobas is performed.
Comparison of progression free survival between T790M positive by MBP-QP using plasma DNA and by cobas is performed.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
100
1st name | |
Middle name | |
Last name | Naoko Aragane |
Saga University Hospital
Division of Respiratory Medicine
5-1-1 Nabeshima, Saga, 849-8501
0952-34-2369
sueokan@cc.saga-u.ac.jp
1st name | |
Middle name | |
Last name | Chiho Nakashima |
Saga University Hospital
Division of Respiratory Medicine
5-1-1 Nabeshima, Saga, 849-8501
0952-34-2369
15624019@edu.cc.saga-u.ac.jp
Division of Respiratory Medicine, Saga University Hospital
AstraZeneca K.K.
Profit organization
NO
2017 | Year | 02 | Month | 01 | Day |
Unpublished
57
No longer recruiting
2017 | Year | 01 | Month | 26 | Day |
2017 | Year | 01 | Month | 12 | Day |
2017 | Year | 02 | Month | 01 | Day |
2021 | Year | 01 | Month | 11 | Day |
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.
2017 | Year | 01 | Month | 31 | Day |
2019 | Year | 08 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029786
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