A Phase II, Single-center, Single-arm trial to evaluate the efficacy of lazertinib in treatment-naive patients for EGFR mutated non-small cell lung cancer with symptomatic or asymptomatic brain metastasis

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

1) Subjects older than 18 regardless of gender.
2) Patients diagnosed as non-small cell lung cancer with brain metastasis
3) NSCLC confirmed with EGFR mutation (E19 del, L858R) by pathology or cytology
4) ECOG performance within 0 to 2.
5) A minimum life expectancy of 3 months.
6) The subjects without any previous chemotherapy including EGFR-TKI.
However, enrollement is possible if patients only have received adjuvant or neoadjuvant chemotherapy or radiotherapy prior to 12 month of enrollment. Local treatment does not affect inclusion criteria.
7) The subject who agreed with effective contraception during the clinical trial period.

Exclusion Criteria

1) evidence of leptomeningeal seeding, spinal cord compression, or intracranial hemorrhage unrelated to cancer.
2) Previous or synchronous cancer other than target lung cancer.
exception) well controlled non-melanoma skin cancer, cervical cancer, intraductal breast cancer, thyroid cancer. Cured cancer more than 3 years of complete remission.
3) Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
4) Any cardiovascular disease as followed:
A History of symptomatic congestive heart failure (CHF) or serious cardiac arrhythmia requiring treatment
B. History of myocardial infarction or unstable angina within 6 months of the first dose of study treatment
5) corrected QTcB > 480msec in 12-lead EKG
6) Known active B viral hepatitis(HBsAg/HBV DNA +), Known C viral hepatitis(HCV RNA +) and/or HIV carrier
7) Women who are pregnant or lactating, or who have a positive pregnancy test before enrollment in the clinical trial
8) Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing the product, or past significant bowel resection that may interfere with the proper absorption of the investigational product.
9) History of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
10) Patients with uncontrolled infectious disease
However, infectious diseases that require parenteral antibiotic administration are excluded, but participation is possible after the infection is completely resolved or controlled.
11) Patients unable to undergo brain MRI or CT examination
12) Patients with a history of hypersensitivity to Lazertinib or its components
13) Patients who have administered other investigational drugs within 30 days prior to trial administration
14) Those who are unable to participate in the clinical trial under the judgment of the investigator, such as when it is difficult to comply with the procedures, restrictions, and requirements of the clinical trial protocol, or if there is no will to follow follow-up management
15) Inadequate bone marrow reserve or organ function as a result of any of the following tests:
• Absolute neutrophil count (ANC) < 1.5 x 109/L
• Platelet count < 100 x 109/L
• Hemoglobin < 9.0 g/dL
• Alanine aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN) if liver metastases cannot be demonstrated, or > 5x ULN if liver metastases are present
• Aspartate aminotransferase (AST) > 2.5x ULN if liver metastases cannot be demonstrated, or > 5x ULN if liver metastases are present.
• Total bilirubin > 1.5x ULN in the absence of liver metastases, or > 3x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases
• Serum creatinine > 1.5x ULN, and creatinine clearance < 50 ml/min as determined by laboratory standard methods (eg Cockcroft and Gault equation)
Confirmation of creatinine clearance is only necessary if creatinine > 1.5x ULN.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival & Intracranial progression free survival

Secondary Outcome Measures

Name	Time	Method
Time to progression ;Intracranial Duration of response;Overall survival;Objective response rate & Intracranial objective response rate;disease control rate & Intracranial disease control rate;Symptomatic change compare to baseline

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A Phase II, Single-center, Single-arm trial to evaluate the efficacy of lazertinib in treatment-naive patients for EGFR mutated non-small cell lung cancer with symptomatic or asymptomatic brain metastasis

Recruitment & Eligibility

Study & Design

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