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OncoMatch/Clinical Trials/NCT05011487

Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

Is NCT05011487 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Osimertinib and Cisplatin for non-small cell lung cancer.

Phase 2RecruitingSun Yat-sen UniversityNCT05011487Data as of May 2026

Treatment: Osimertinib · Cisplatin · PemetrexedThis is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR ex19del

A tumour which harbours 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 (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).

Required: EGFR L858R

A tumour which harbours 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 (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).

Disease stage

Required: Stage IIIA, T3-4N2 IIIB (IASLC Version 8)

Excluded: Stage T4 TUMOURS INFILTRATING THE AORTA, THE OESOPHAGUS AND/OR THE HEART, ANY BULKY N2 DISEASE DEEMED UNRESECTABLE

resectable (Stage IIIA or T3-4N2 IIIB) disease (according to Version 8 of the IASLC Cancer Staging Manual)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic anti-cancer therapy

Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug

Cannot have received: EGFR tyrosine kinase inhibitor

Prior treatment with EGFR-TKI therapy

Cannot have received: radiation therapy

Exception: pre-operative only

Patients who have pre-operative radiotherapy treatment as part of their care plan

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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