EGFR mutation-positive non-small cell lung cancer
Conditions
Interventions
Continue to administer osimertinib to a patient until the patient correspond to the withdrawal criteria
Sponsors
Kobe City Medical Center General Hospital Department of medical oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Non-small cell lung cancer (except for squamous cell carcinoma) diagnosed histologically or cytologically 2) Patients with EGFR mutation (Exon 19 deletion or Exon21 L858R) positive, who were received treatment by EGFR tyrosine kinase inhibitors 3) Patients with clinical stages IIIB, IIIC or IV or postoperative recurrence which are confirmed with diagnostic radiology 4) EGFR T790M positive cytology positive 5) Enrollment after 12 weeks from radiation therapy including lung area and after 1 week from radiation therapy not including lung area 6) Age: more than 20 years old at the date or informed consent 7) Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1 8) Patients who have measurable lesion designated by RECIST version 1.1 9) Patients with adequate organ function 10) Enrollment after 21 days from the starting date of last cytotoxic anticancer agents or after 4 days from the last dose of EGFR tyrosine kinase inhibitors 11) Patients expected to survive for more than 12 weeks 12) After the details of the trial are explained sufficiently before enrollment in this trial, written consent by patients themselves should be obtained
Exclusion criteria
Exclusion criteria: 1) Treatment history of osimertinib or other third-generation EGFR tyrosine kinase inhibitors (ex. ASP8273) 2) Patients who received other EGFR-tyrosine kinase inhibitors again after disease progression 3) Treatment history of immune checkpoint inhibitors 4) QTc >470 msec 5) Patients with interstitial pneumonia, pulmonary fibrosis or radiation pneumonitis on chest CT 6) Patients with history of drug-related interstitial lung disease 7) Patients with history of serious drug allergy 8) Patients with serious infection or other serious concomitant disease (ex. gastrointestinal bleeding) 9) Uncontrollable pleural effusion, ascites or pericardial effusion 10) Clinically problematic heart disease 11) Uncontrollable diabetes 12) Central nervous system metastasis with a clinical manifestation 13) Patients with active double cancer 14) Clinically problematic psychiatric disorders 15) Unhealed fracture or heavy wound 16) Pregnant or breast-feeding female patients, female patients who have a possibility of pregnancy and does not intend to use birth control till after 6 weeks after last administration or male patients who does not intend to use birth control till after 4 months after last administration 17) Patients judged to be ineligible for safe implementation of this trial by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate: from first administration to last administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) disease control rate 2) progression-free survival 3) safety (adverse event) | — |
Countries
Japan
Contacts
Public ContactTatsushi Goto
Secretariat of clinical trial coordinating committee none
Outcome results
None listed