Actively Recruiting
Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
Led by Konkuk University Medical Center · Updated on 2022-07-21
40
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
K
Konkuk University Medical Center
Lead Sponsor
Y
Yuhan Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Patients with suspected lung cancer on chest CT findings
- Presence of specific EGFR gene mutations detected by bronchoalveolar lavage fluid test, including E19Del, L858R alone or with T790M, G719X, exon 20 insertion, or S768I
- Tumor that can be completely removed by surgery: stage I-IIIB, or stage IVA with single metastasis
- No previous treatment with EGFR-TKIs such as gefitinib, erlotinib, afatinib, or dacomitinib
- Measurable lesion of 1 cm or larger according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate lung and heart function for surgery
- Adequate organ function including hemoglobin ≥ 9.0g/dL, neutrophil count ≥ 1500/mm3, platelet count ≥ 100,000/mm3, normal or acceptable serum creatinine, liver enzymes, and bilirubin levels
- Female patients of childbearing potential must use effective contraception or be post-menopausal (defined as over 50 years old and no menstruation for at least 12 months)
- Male patients with female partners of childbearing potential must use effective contraception or have had a vasectomy for specified periods
You will not qualify if you...
- Uncontrolled active interstitial lung disease
- Pathologically confirmed N3 disease
- Uncontrolled stage III-IV malignancy other than lung cancer
- Uncontrolled hypertension, severe congestive heart failure (NYHA class ≥3), recent heart attack within 6 months, or certain heart conduction blocks
- Gastrointestinal diseases such as Crohn's disease, ulcerative colitis, or malabsorption syndrome affecting drug absorption
- Active infections requiring treatment, including active hepatitis B, hepatitis C, or HIV
- History of allergy to lazertinib or related drugs
- Inability to comply with study protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Konkuk University Medical Center
Seoul, South Korea, 05030
Actively Recruiting
Research Team
I
In Ae Kim, MD. PhD.
CONTACT
K
Kye Young Lee, MD,PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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