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

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05469022
Collaborator
Yuhan Corporation (Industry)
40
Enrollment
1
Location
1
Arm
60
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Neoadjuvant lazertinib
 Phase 2

Detailed Description

The neoadjuvant treatment of 3rd-generation EGFR-TKI, lazertinib for 9 weeks before surgery is administrated. After the surgery, the patients with the tumor over stage 2 are given the lazertinib to prevent recurrence for 3 years or until recurrence. In early lung cancer, a tissue biopsy is often difficult due to the small size or the risky location. We collect bronchoalveolar lavage fluid for liquid biopsy and lazertinib is administrated according to the result of BALF liquid EGFR genotyping.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Single-Center, Single-Arm, Prospective Study of Neoadjuvant Lazertinib Therapy in Resectable EGFR-Mutation Positive Lung Adenocarcinoma Patients Detected by Broncho-alveolar Lavage Fluid(BALF) Liquid Biopsy
Actual Study Start Date :
May 19, 2022
Anticipated Primary Completion Date :
May 19, 2024
Anticipated Study Completion Date :
May 19, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Neoadjuvant Lazertinib

Lazertinib as neoadjuvant treatment is administrated for 9 weeks before surgery. After surgical intervention the treatment is administrated upto 3 years to the patients with over stage 2 tumor. Treatment is discontinued in case of unacceptable toxicity or disease progression.

Drug: Neoadjuvant lazertinib
Lazertinib 240mg p.o once daily.
Other Names:
  • Neoadjuvant LECLAZA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate [9 weeks after the starting day of the lazertinib]

      The objective response rate (ORR) evaluated with RECIST version 1.1. It is defined as the proportion of patients with complete response (CR) or partial response (PR) after 9 weeks of lazertinib administration

    Secondary Outcome Measures

    1. Down-staging rate [From the day of screening to an average of 16 weeks after the first dose]

      The rate of downstage by pathology stage compared with clinical stage

    2. Major pathological response [From the day of screening to an average of 16 weeks after the first dose]

      The proportion of patients with less than 10% of the cancer cells in the surgical sample.

    3. Disease-free survival rate [up to 3 years after surgery]

      The length of time after surgical resection the patient remains free of recurrence/progression or death, whatever the cause.

    4. The concordance rate of EGFR mutations between surgical tissue and BAL fluid samples [From the day of screening day to an average of 16 weeks after the first dose]

      The concordance rate of BALF EGFR mutation compared with EGFR mutation status of surgical resected tissue

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 range1.5x Aminotransferase/Alkaline phosphatase ≤normal range2.5x 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konkuk University Medical Center Seoul Korea, Republic of 05030

    Sponsors and Collaborators

    • Konkuk University Medical Center
    • Yuhan Corporation

    Investigators

    • Principal Investigator: Kye Young Lee, Konkuk University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kye Young Lee, Professor, Konkuk University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05469022
    Other Study ID Numbers:
    • NeolazBAL
    First Posted:
    Jul 21, 2022
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kye Young Lee, Professor, Konkuk University Medical Center
    EGFR mutation
    extracellular vesicle
    bronchoalveolar lavage
    liquid biopsy
    lazertinib
    Additional relevant MeSH terms:
    Adenocarcinoma
    Adenocarcinoma of Lung
    Lazertinib

    Study Results

    No Results Posted as of Jul 21, 2022