None listed
Conditions
Interventions
Drug : All enrolled subjects will receive Lazertinib 160 mg once daily.
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Inclusion Criteria] (1) Pathologically diagnosed non-small cell lung cancer. (2) Patients with advanced stage lung cancer that cannot be curatively treated with surgery or radiotherapy and require palliative therapy. (3) Patients who are EGFR mutation positive and have developed resistance to at least one agent, including first-generation EGFR inhibitors (gefitinib, erlotinib) or second-generation inhibitors (afatinib, dacomitinib), while taking or after taking at least one agent, and subsequent genetic testing (PCR test or NGS test) of blood or lung cancer tissue confirms the EGFR T790M resistance gene. (4) Are able to take the study drug (lazertinib) by mouth or through a Levin tube. (5) Capable of making an informed decision to participate in this study (6) 19 years of age or older (7) ECOG 0-2 (8) Minimum life expectancy of 12 weeks (9) Adequate organ function (10) Female patients must be of non-childbearing potential or agree to use adequate contraception for the duration of the study. (11) Signed written informed consent
Exclusion criteria
Exclusion criteria: [Exclusion Criteria]. (1) Subjects who have previously developed resistance after taking a third-generation EGFR tyrosine kinase inhibitor (such as osimertinib). However, those who are unable to take osimertinib due to intolerable side effects of osimertinib prior to the development of resistance after taking osimertinib, etc. and need to take lazertinib as an alternative to osimertinib are eligible. (2) In the judgment of the physician, participation in this study would cause more harm than good to the patient: No specifics. (3) Uncontrolled central nervous system metastases. - Patients with asymptomatic brain metastases or investigator-assessed CNS symptoms that are curable with an EGFR-TKI may be enrolled. (4) Uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, or active infection. (5) Therapy with radiation from a large field of irradiation within 1 week or therapy with radiation from a limited field of irradiation for palliative purposes within 1 week (local radiation therapy or gamma knife surgery). (6) Symptoms not relieved by prior therapy, > CTCAE grade 1. (7) Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with Lazertinib dose adjustment to less than 160 mg of Lazertinib (Percentage of patients with dose reduction + Percentage of patients with treatment termination due to toxicity) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event distribution by CTCAE.;Objective Response Rate (according to RECIST1.1(Response Evaluation Criteria In Solid Tumours) guideline);Progression-free survival;Overall survival;Pharmacokinetic Testing of Lazertinib 160mg | — |
Countries
Korea, Republic of
Contacts
Public ContactJongmu Sun
Samsung Medical Center
Outcome results
None listed