OncoMatch/Clinical Trials/NCT04853342
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
Is NCT04853342 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Drug: Furmonertinib 80 mg for non-small cell lung carcinoma.
Treatment: Drug: Furmonertinib 80 mg — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR ex19del, L858R
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.
Disease stage
Required: Stage IB, II, IIIA
Performance status
WHO 0–1
Prior therapy
Must have received: surgery — curative (complete resection)
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.
Cannot have received: radiation therapy
Pre-operative or post-operative or planned radiation therapy for the current lung cancer
Cannot have received: platinum-based chemotherapy
Pre-operative (neo-adjuvant) platinum-based or other chemotherapy
Cannot have received: cytotoxic chemotherapy
Any prior anticancer therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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