None listed
Conditions
Interventions
Drug : This study, as an exploratory study, sees the efficacy of combination therapy of razanitip and pemetrexed/carboplatin in each cohort.
Treatment: Daily dose of Lazertinib and 3-week interval Pem
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 18 and above 2) Measurable disease according to RANO following RECIST1.1 or meningeal metastasis 3) 3) ECOG PS 0-1 4) Non-small cell lung cancer developed after receiving first or second-generation TKI treatment due to EGFR mutation. 5) If T790M is confirmed 6) Appropriate organ function should be shown. not more than three times the normal serum AST/ALT limit (not more than five times if liver metastasis is present) Less than twice the normal serum Bilirubin limit (excluding Gilbert syndrome) Creatine cleaning rate > 45 ml/min Absolute neutrophils > 1,500/uL Platelet count > 75,000/uL Hemoglobin >9 g/L 7) Life expectancy at the discretion of the tester > 3 months 8) Voluntary consent
Exclusion criteria
Exclusion criteria: 1) If 3rd generation EGFR TKI was used as the primary therapy 2) EGFR exon 20 insertion 3) Surgical or radiotherapy within 2 weeks of treatment 4) Cerebral metastasis or softening membrane metastasis requiring immediate local or high doses of steroid therapy 5) If you have spinal compression symptoms. 6) History of other malignant tumors. However, this is an exception when the tester determines that the condition of remission is completely cured due to the effectively treated non-black tumor, cervical epithelial cancer, vascular epithelial cancer, and remission lasting more than 5 years. 7) Known existing epileptic lung disease 8) Unregulated NYHA Grade 3 or higher congestive heart failure 9) myocardial infarction within six months 10) If there is known hypersensitivity to drugs. 11) If the tester does not have the will or ability to comply with the clinical trial plan, 12) If you are currently pregnant or breastfeeding or have plans for pregnancy during clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Assessment Variables: Progression-free survival of each cohort Secondary Assessment Variables: Objective response rate and survival of each cohort, safety assessment (CTCAE version 5), and the mechanism of resistance through tissue and blood | — |
Secondary
| Measure | Time frame |
|---|---|
| It is assumed that the progression pattern of patients always follows the Weibull distribution shape parameter 1 with a constant progress rate. In addition, considering that it is an exploratory study, the 0.15 significance level was adopted for 80% power.Used PASS 2021 program | — |
Countries
Korea, Republic of
Contacts
Public ContactYoonsook Kang
Asan Medical Center
Outcome results
None listed