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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.

Phase 3RecruitingAllist Pharmaceuticals, Inc.NCT04853342Data as of May 2026

Treatment: Drug: Furmonertinib 80 mgThis 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines
Min 0 prior lines

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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