Prospective study for usefulness of plasma DNA on prediction of third generation EGFR tyrosine kinase inhibitors
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000025930
- Lead Sponsor
- Division of Respiratory Medicine, Saga University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 57
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of overall response rate between T790M positive by MBP-QP using plasma DNA and by cobas is performed.
- Secondary Outcome Measures
Name Time Method Comparison of progression free survival between T790M positive by MBP-QP using plasma DNA and by cobas is performed.