OncoMatch/Clinical Trials/NCT05469022
Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
Is NCT05469022 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Neoadjuvant lazertinib for non small cell lung cancer.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Non-Small Cell Lung Carcinoma
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT05469022 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR L858R is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or IIIA or IIIB or IVA is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages