NCT05469022 Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
| NCT ID | NCT05469022 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Konkuk University Medical Center |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-05-19 |
| Primary Completion | 2024-05-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2022-05-19 with a primary completion date of 2024-05-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 19 years 2. Patients with suspected lung cancer on chest CT findings 3. Patients with the following EGFR gene mutations in the test on bronchoalveolar lavage fluid: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I) 4. Patients whose tumor can be completely resected by surgery: patients with stage I-IIIB, or stage IVA who has single metastasis 5. Patients not previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib 6. Patients with the measurable lesion of 1 cm or more according to RECIST v1.1 7. Eastern Cooperative Oncology Group (ECOG) 0-1 8. EGFR-TKIs (gefitinib, erlotinib, afatinib,dacomitinib) naive patients 9. Patients with adequate pulmonary and heart function for surgery 10. 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 11. Female patients with childbearing potential should be using adequate contraceptive measures. Female patients must have evidence of non-child-bearing potential(Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments) 12. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least 14 days prior to administration of the first dose of study treatment, during the study, and for 3 months following the last dose of Lazertinib. Exclusion Criteria: 1. Uncontrolled active interstitial lung disease 2. Pathologically confirmed N3 disease 3. Uncontrolled stage III-IV other malignancy 4. Uncontrolled Hypertension, Congestive Heart failure with New York Heart Association(NYHA) ≥ 3, acute myocardial infarct history within 6 months before screening. 2nd- 3rd Atrio-Ventricular(AV) block or complete AV block 5. Gastrointestinal diseases (e.g. Chron's disease, ulcerative colitis) or malabsorption syndrome that would impact on drug absorption 6. Active infection requiring ongoing treatment(e.g. active Hepatitis B virus, Hepatitis C virus or Human immunodeficiency virus) 7. History of hypersensitivity to active or inactive excipients of Lazertinib or drugs with a similar chemical structure. 8. No ability to comply with protocol requirements.
Contact & Investigator
Kye Young Lee
PRINCIPAL INVESTIGATOR
Konkuk University Medical Center
Frequently Asked Questions
Who can join the NCT05469022 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05469022 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05469022 currently recruiting?
Yes, NCT05469022 is actively recruiting participants. Contact the research team at 20180618@kuh.ac.kr for enrollment information.
Where is the NCT05469022 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05469022 clinical trial?
NCT05469022 is sponsored by Konkuk University Medical Center. The principal investigator is Kye Young Lee at Konkuk University Medical Center. The trial plans to enroll 40 participants.
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