T790M-positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
Interventions
Group A: Osimertinib monotherapy Consecutively administer oral dose of osimertinib at 80 mg/day every day at almost the same time for 3 weeks as one course, and continue treatment unless any of the d
Sponsors
Lung Oncology Group in Kyushu (LOGIK)/North East Japan Study Group(NEJSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Clinical stage IIIB or IV or postoperative recurrent non-squamous non-small cell lung cancer harbouring susceptible EGFR mutations (G719X mutation, exon 19 deletion, L858R mutation, L861Q mutation) that cannot be treated with curative radiotherapy 2) Aggravation confirmed by imaging diagnosis after treatment with the first- and second-generation EGFR-TKI and T790M mutation confirmed in tumor tissue specimens or blood specimen after exacerbation 3) No history of treatment with cytotoxic drugs. However, the patients who received the final dose more than one year prior to enrollment are eligible in case of recurrence after pre-or postoperative adjuvant chemotherapy. 4) At least 8 days passed after the final dose of EGFR-TKI. 5) Aged 20 years or older at the time of informed consent 6) ECOG performance status (PS): 0 or 1 7) No palliative radiotherapy for metastatic lesion(s) (including gamma knife therapy for brain metastasis within 7 days) within 14 days before enrollment 8) No Grade 3 or higher superior vena cava syndrome, pericardial effusion, pleural effusion, or ascites 9) Irrespective of measurable lesion 10) All of the following criteria are met based on the laboratory data at the start of treatment (The data obtained within 14 days of enrollment: the same day of the week 2 weeks before enrollment is allowed): 1.WBC count:>=3000 /mm3 2.Neutrophil count:>=1500 /mm3 3.Hemoglobin:>= 9.0 g/dL (no blood transfusion within 14 days of screening) 4.Platelet count:>=10X10,000/mm3 5.AST:=< 100 IU/L 6.ALT:=< 100 IU/L 7.Total bilirubin:=< 1.5 mg/dL 8.SpO2:>=92 % (room air). Patients with SpO2 <92% are eligible if PaO2 is >=60 torr. 9.Creatinine:=<1.2 mg/dL 10. Creatinine clearance >=45 mL/min However, Ccr shall not exceed 120 (ml/min). 11)Have given written consent to participate in the study after receiving detailed explanation of the study
Exclusion criteria
Exclusion criteria: 1) Active double cancer (simultaneous double cancer/multiple cancer, and metachronous double cancer/multiple cancer within 5 years of disease-free period. However, carcinoma in situ and a lesion equivalent to intramucosal carcinoma judged cured by local therapy are not included as active double cancer/multiple cancer). 2) Evidence of interstitial pneumonia or pulmonary fibrosis by chest CT scan /Radiation pneumonitis which required steroid treatment 3) Not able to swallow oral medications 4) Previous treatment history of immune checkpoint inhibitors 5) Infection requiring systemic treatment 6) Fever of >=38(axillary temperature) at the time of enrollment 7) Psychosis or psychotic symptoms that may interfere with the patient's participation in the study 8) Symptomatic brain metastasis (clinically stable brain metastasis is eligible) 9) Adverse event of >=Grade 2 considered attributable to EGFR-TKI of the prior therapy 10) Receiving continuous systemic (oral or intravenous) immunosuppressant therapy 11) Complication of diabetes mellitus treated with continued use of insulin or poorly controlled diabetes mellitus 12) Complication of unstable angina (new-onset angina or exacerbation of angina within the last 3 weeks) or history of myocardial infarction within 6 months. 13) HBs antigen-positive 14) Pregnant or possibly pregnant women, lactating women, or patients who wish to become pregnant 15) Patients who, in the opinion of the attending physician, are inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, overall survival, incidence of adverse events | — |
Countries
Japan
Contacts
Public Contact(1) Kentaro Tanak,(2) Hajime Asahina
(1) Kyushu University,(2) Hokkaido University School of Medicine (1) Research Institute for Diseases of the Chest,(2) First Department of Medicine
Outcome results
None listed