This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of Furmonertinib (AST2818) versus placebo in patients with stage II-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy.
Male or female, aged at least 18 years.
Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.
MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
Patients must be classified post-operatively as Stage IB, II, or IIIA on the basis of pathologic criteria.
Pre-operative or post-operative or planned radiation therapy for the current lung cancer
Pre-operative (neo-adjuvant) platinum-based or other chemotherapy
Any prior anticancer therapy
Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time