OncoMatch/Clinical Trials/NCT05469022

Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy

Is NCT05469022 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Neoadjuvant lazertinib for non small cell lung cancer.

Phase 2RecruitingKonkuk University Medical CenterNCT05469022Data as of May 2026

Treatment: Neoadjuvant lazertinib — Complete surgical resection is the standard treatment in early-stage lung cancer. However, the patients with early resected Epidermal Growth Factor Receptor(EGFR)-mutated lung cancers have high recurrence rate. The efficacy of neoadjuvant treatment by first-generation EGFR-Tyrosine Kinase Inhibitor(TKI) has been demonstrated, however, that of the third-generation EGFR-TKI(lazertinib) has not yet been fully investigated. The aim of this study is to evaluate the efficacy of neoadjuvant Lazertinib in resectable EGFR mutation-positive NSCLC and clinical application of extracellular vesicles(EVs) based BALF liquid biopsy to identify EGFR mutation without invasive tissue biopsy.

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Biomarker criteria

Required: EGFR exon 19 deletion

EGFR gene mutations in the test on bronchoalveolar lavage fluid: E19Del

Required: EGFR L858R

EGFR gene mutations in the test on bronchoalveolar lavage fluid: L858R

Allowed: EGFR T790M

concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)

Allowed: EGFR G719X

concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)

Allowed: EGFR exon 20 insertion

concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)

Allowed: EGFR S768I

concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)

Disease stage

Required: Stage I, II, IIIA, IIIB, IVA

patients with stage I-IIIB, or stage IVA who has single metastasis; Pathologically confirmed N3 disease [excluded]

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: egfr tyrosine kinase inhibitor (gefitinib, erlotinib, afatinib, dacomitinib)

Lab requirements

Blood counts

Hemoglobin ≥ 9.0g/dL; Absolute neutrophil count ≥ 1500/mm3; Platelet ≥ 100,000 /mm3

Kidney function

Serum creatinine ≤ normal range*1.5x

Liver function

Aminotransferase/Alkaline phosphatase ≤ normal range*2.5x; Total bilirubin ≤1.5 mg/dL; Liver metastasis: Aminotransferase/Alkaline phosphatase ≤ normal range* 5x

Cardiac function

adequate pulmonary and heart function for surgery

Adequate organ function defined as Hemoglobin ≥ 9.0g/dL Absolute neutrophil count ≥ 1500/mm3 Platelet ≥ 100,000 /mm3 Serum creatinine≤ normal range*1.5x Aminotransferase/Alkaline phosphatase ≤normal range*2.5x Total bilirubin ≤1.5 mg/dL Liver metastasis: Aminotransferase/Alkaline phosphatase ≤ normal range* 5x Bone metastasis Alkaline phosphatase ≤ normal range* 5x; adequate pulmonary and heart function for surgery

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

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