EGFR activating mutation-positive untreated advanced or recurrent non-small cell lung cancer
Conditions
Interventions
Patients with body weight of 50kg or less will be treated with osimertinib 40mg daily. Patients will be followed every 6 months after start of the treatment until December 2027.
Patients with body wei
Sponsors
Public Health Research Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically proven non-small cell lung cancer. (2) EGFR activation mutation-positive, either exon19 partial deletion or exon21 L858R point mutation. Liquid biopsy allowed for detection of the mutation. (3) Patients with either stage IV or stage III disease not amenable to radical chemoradiotherapy. Those with recurrent disease after curative surgery or definitive (chemo)radiotherapy are also eligible. (4) Patients scheduled to be treated with osimertinib monotherapy. (5) No prior systemic drug therapy for the disease. Patients with prior adjuvant chemotherapy are allowed; those with prior adjuvant EGFR-TKI are excluded. (6) 70 years of age or older at the date of enrollment. (7) Performance status must be 0, 1 or 2 according to ECOG criteria. (8) Body weight of 25 kg or more, and less than 100 kg. (9) Those without measurable lesions are allowed. (10) No symptomatic brain metastases, meningeal carcinomatosis, or spinal metastases requiring radiation therapy or surgery. However, patients may be enrolled after appropriate local treatment. (11) No exclusion criteria are set on laboratory values, if the attending physician judges that osimertinib can be safely administered. (12) Patients who are currently participating or will participate in other clinical trials or observational studies could be enrolled into this study unless otherwise specified. (13) Written informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: (1) Those with infection requiring systemic treatment. (2) Those with obvious interstitial pneumonia diagnosed by chest CT scan; a history of radiation pneumonitis or organizing radiation pneumonitis in the irradiated field is allowed. The presence or absence of interstitial pneumonitis shall be judged by the attending physician. (3) Those with concomitant or treated malignancy with possibility of recurrence within 2 years, which could affect assessment of the primary endpoint. (4) Those with psychiatric disorder or symptoms that affect daily life, thereby make participation in the study difficult. (5) Those with complications which are judged unsuitable for study participation, such as uncontrollable diabetes mellitus, uncontrollable hypertension, congestive heart failure, unstable angina pectoris, serious arrhythmia, severe cerebrovascular disease, etc. (6) Those with other complications or pre-existing medical conditions that would make participation in this study difficult, as judged by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival(OS), time to treatment failure (TTF), response rate (RR), incidence of adverse events, and QOL. | — |
Countries
Japan
Contacts
Public ContactYoko Tsukita
MONEY Study Office Tohoku University Graduate School of Medicine, Dept of Respiratory Medicine
Outcome results
None listed