This is an open label, phase II study 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 IB-IIIA lung adenocarcinoma.
Provision of informed consent prior to any study specific procedures
Adult male or female patients, aged from 30 to 75 years
Pathologic proven 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
The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion.
Regression of synchronous GGN after adjuvant chemotherapy prior to osimertinib
Past history of postoperative ALI/ARDS or pneumonia during recovery period
Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 week prior) (Appendix C). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
Parallel
Osimertinib 80Mg Tab
DrugSubjects have a osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection
To assess the efficacy of osimertinib on the regression of additional GGN(s)
Regression rate of each individual GGN using investigator assessments by comparing the size of GGN(s) on the initial CT scan (at screening) to that in the last follow-up scan, assessed by a blinded independent central review (BICR) of the radiologic examination of each patient; We will conduct the quantitative analysis of GGNs on the initial and follow-up CT scans via VOI (Volume of Interest) segmentation. The findings of each GGN on the initial and follow-up CT scans will be analyzed as follows: (1) diameter of the GGO component, (2) diameter of the solid component, (3) volume, (4) mass, (5) density, and (6) a histogram of CT attenuation. Regression is defined as follows: (1) disappearance of GGN, 2) more than 25% decrease in longest diameter and no increase of mean density or 3) documented evidence of 25% decrease in kurtosis, skewness, mean density or mass in case of less than 25% decrease in longest diameter
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