A phase II study for the evaluation of the feasibility of lazertinib 160 mg per day in patients with EGFR T790M mutant non-small cell lung cancer

Samsung Medical Center0 个研究点目标入组 117 人开始时间: 待定最近更新: 2024年3月4日

适应症

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•[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].
•(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.

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