Comprehensive study for the potential blood-based biomarkers for NSCLC patients treated with lazertinib
- Conditions
- Neoplasms
- Registration Number
- KCT0008254
- Lead Sponsor
- Kyung Hee University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
1) A person who has given written consent to participate in this study
2) Adult men and women over 19 years of age
3) Patients with histologically or cytologically confirmed non-small cell lung cancer
4) Patients scheduled to receive Lazertinib after T790M mutation was confirmed positive after treatment failure with 1st or 2nd generation EGFR-TKIs
5) Patients with ECOG PS of 0~2
1) Patients who have received systemic steroid or immunosuppressant treatment within 2 weeks prior to Lazertinib administration
2) Patients who received antibiotic treatment within 2 weeks prior to Lazertinib administration
3) Patients currently being treated for connective tissue disease or inflammatory bowel disease
4) Patients confirmed as positive for ALK fusion
5) Patients with confirmed malignant tumors prior to participating in this study
However, registration is possible in the following cases, but registration is not possible if the patient is accompanied by a malignant tumor requiring current treatment.
- Cases confirmed as malignant tumors (including lung cancer) but in remission for more than 5 years after completion of treatment
-Efficiently treated non-melanoma skin cancer, cervical carcinoma in situ, mammary ductal carcinoma in situ, localized prostate cancer, and thyroid cancer treated for curative purposes can be registered.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival, PFS
- Secondary Outcome Measures
Name Time Method Objective Response Rate, ORR;Duration of Response, DoR;Overall Survival, OS;PIV(pan-immune-inflammation value), NLR(Neutrophil-Lymphocyte Ratio), PLR(platelet-lymphocyte ratio), SIRI(Systemic Inflammation Response Index)