None listed
Conditions
Interventions
None listed
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects 20 years of age or older 2. Histologically or cytologically confirmed patients with advanced or metastatic NSCLC 3. Patients confirmed as positive for T790M mutation as a result of plasma EGFR test 4. Patients who were treated by the first and the second generation EGFR-TKI for the treatment of NSCLC and are planning to initiate the treatment of Lazertinib 5. Patients with functional status score (Performance Status, PS) for 0-2 points according to the Eastern Cooperative Oncology Group (ECOG) for the past 2 weeks 6. The participants who provide the signed and dated written informed consent document prior to specific procedures for this study.
Exclusion criteria
Exclusion criteria: 1. Patients already being treated or treated with the 3rd generation EGFR tyrosine kinase inhibitors (TKIs) 2. All malignancies other than prior or concurrent disease under study However, except for the following : patients who have been adequately treated for non-melanomatous skin cancer , carcinoma in situ of the cervix , ductal carcinoma in situ of the breast , thyroid cancer, or malignancies that have been adequately treated and have been in remission for more than 3 years and are curatively treated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) according to T790M allele frequency after Lazertinib treatment in patients with advanced or metastatic NSCLC | — |
Secondary
| Measure | Time frame |
|---|---|
| Time on treatment (TOT) according to T790M allele frequency after Lazertinib treatment in patients with advanced or metastatic NSCLC;PFS(Progression-free survival) according to T790M allele frequency after Lazertinib treatment in patients with advanced or metastatic NSCLC;Sensitivity and specificity of PRIME EGFR Kit compared to other tests using plasma or tissue;Positive predictive value and negative predictive value of PRIME EGFR Kit compared to other tests using plasma or tissue;Comparison of the frequency of the T790M allele and the difference in prognosis between the high frequency group and the low frequency group by dividing the frequency;The allele frequency of the T 790M mutation and the allele frequency of the EGFR activating mutation and evaluate value as a predictor between T790M mutant allele frequency/EGFR activation mutant allele frequency ratio;Identify the mechanisms of acquired resistance using Next Generation Sequencing (NGS) in blood samples in the underlying and advanced state of patients treated with Lazertinib | — |
Countries
Korea, Republic of
Contacts
Public ContactLee Jae Cheol
Asan Medical Center
Outcome results
None listed