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OncoMatch/Clinical Trials/NCT06383728

Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma

Is NCT06383728 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Osimertinib for lung cancer.

Phase 2RecruitingThe First Affiliated Hospital of Guangzhou Medical UniversityNCT06383728Data as of May 2026

Treatment: OsimertinibPrevious trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains controversial.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR mutation

Disease stage

Required: Stage II, IIIA, IIIB

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

ANC ≥ 1.5 × 10^9, platelet ≥ 100 × 10^9, hemoglobin ≥ 90g/L; INR or PT ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN

Kidney function

Good function of kidney

Liver function

serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be < 3×ULN); AST and ALT ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN

Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be < 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN

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

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