A Phase II Study of Osimertinib to Suppress the Progression of Remaining Ground-glass Opacity Nodule (GGN) for Actionable EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
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.
⁃ WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
⁃ Complete surgical resection of the primary NSCLC is mandatory.
⁃ Uneventful recovery from curative-intent lung cancer surgery
∙ For assignment in the control arm, subjects should be classified post-operatively as Stage IA on the basis of pathologic criteria (the 8th edition of TNM staging system for lung cancer).
∙ For assignment in the treatment arm, subjects should fulfil the following criteria in addition to the above criteria.
• Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic cirteria (the 8th edition of TNM staging system for lung cancer)
• Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
‣ Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
⁃ Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
⁃ Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
∙ Further information in Appendix E (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods)
∙ \- Male subjects should be willing to use barrier contraception during the study and for 4 months after last dose of osimertinib