This study designed to assess the efficacy of osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection for actionable EGFR mutation-positive stage I lung adenocarcinoma.
Name: Osimertinib 80 MG
Description: Regression rate of additional GGNs using investigator assessments by comparing the size of GGN(s) on the initial CT scan (at randomization) to that in the last follow-up scan. We will conduct the quantitative analysis of GGNs on the initial and follow-up CT scans via VOI (Volume of Interest) segmentation. VOI is measured with the unit of mm3.
Measure: To assess the efficacy of osimertinib on the regression of additional GGN(s) Time: up to 12monthsDescription: Avoidance rate of subsequent surgeries or radiation treatments for GGN(s) within one year since the initiation of osimertinib treatment: Defined as the number (percent) of patients who do not require subsequent anticancer treatments including surgeries or radiation for remaining GGN(s) within one year since the initiation of osimertinib treatment
Measure: To assess the efficacy of osimertinib in avoidance of subsequent anticancer treatments including surgery or radiation for GGN(s) Time: up to 12monthsDescription: Time to regression: Defined as the length of time from the date of initiation of osimertinib treatment to the first date of GGN regression
Measure: To evaluate when GGN(s) will regress after osimertinib treatment Time: up to 12monthsDescription: Incidence of regrowth and reappearance of remaining GGN(s) within one year since the initiation of osimertinib treatment
Measure: To evaluate the rate of treatment failure Time: up to 12monthsDescription: Number of patients who would have growing new nodules (either ground glass nodules or solid nodules) with high suggestion of lung cancer by lung-special radiologists within one year since the initiation of Osimertinib treatment
Measure: To evaluate the number of patients with new nodules Time: up to 12monthsDescription: Incidence of adverse events and grades based on CTCAE (Common Terminology Criteria for Adverse Events) version 5.0.
Measure: To assess the incidence of treatment-emergent adverse events of osimertinib Time: up to 12monthsAllocation: Randomized
Parallel Assignment
There is one SNP
Incidence of adverse events and grades based on CTCAE (Common Terminology Criteria for Adverse Events) version 5.0.. Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Adult male or female patients, aged from 30 to 75 years 3. Pathologic proven stage I lung adenocarcinoma with additional persistent GGNs in at least one other lobe: GGN is defined as a ground glass-opacity with well-defined margin, mean density above -500 HU and greater than 7.5 mm in its maximum diameter 4. The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion. --- L858R ---
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Adult male or female patients, aged from 30 to 75 years 3. Pathologic proven stage I lung adenocarcinoma with additional persistent GGNs in at least one other lobe: GGN is defined as a ground glass-opacity with well-defined margin, mean density above -500 HU and greater than 7.5 mm in its maximum diameter 4. The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion. --- L858R ---