To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. * Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M. * Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for the tumor. * Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization. * World Health Organization Performance Status of 0 to 1. * Fe