Non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
Division of Respiratory Medicine, Saga University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of overall response rate between T790M positive by MBP-QP using plasma DNA and by cobas is performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of progression free survival between T790M positive by MBP-QP using plasma DNA and by cobas is performed. | — |
Countries
Japan
Contacts
Public ContactChiho Nakashima
Saga University Hospital Division of Respiratory Medicine
Outcome results
None listed