Non small cell lung cancer
Conditions
Interventions
EGFR T790M:ctDNA sequencing
Sponsors
Cancer Control Center of SUN YAT-SEN University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older; 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); 3. AJCC diagnosed by clinical pathological staging Stage IV NSCLC patients in TNM stage (8th edition); 4. The EGFR must be defined before administration of Osmertinib T790m mutation positive; 5. According to RECIST 1.1. The patient has at least one tumor lesion that can be measured or evaluated; the lesions that have been previously treated with radiotherapy are not used as lesions or biopsy lesions, unless the lesion is clearly progressing after radiotherapy; 6. The lesion is not suitable for surgical removal; 7. The Eastern oncology group strength status score (ECoG) was 0-1, with no signs of deterioration in the last 2 weeks; 8. Expected survival time > 12 weeks; 9. The clinical laboratory examination indicators meet the following standards: Platelet=100 x 10^9/L; Absolute neutrophil count (ANC) =1.5x10^9/L; Hemoglobin (Hgb) =90 g/L; Upper limit of total bilirubin=1.5 times normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) =3-fold ULN (=5 ULN if liver metastasis is present); Creatinine=1.5 times ULN or creatinine clearance=50 mL/min; 10. Patients should sign informed consent forms before conducting any research-related procedures, sampling and analysis. They should be able to provide tissue samples/blood samples and to cooperate in observing adverse times and effects; 11. Be able to swallow and take oral medication; 12. In addition to hair loss and stable peripheral neurotoxicity below grade 2, any clinical toxicity associated with pre-admission treatment must be restored to baseline or level 1; 13. Women of childbearing age should take appropriate contraceptive measures in the course of the study, and should not be breastfed during the screening stage, the research stage and within 3 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1. Non-treated NSCLC patients; 2. Unwilling to Provide Blood for Genetic Testing; 3. Osmertinib before treatment for EGFR The T790M variant state is unknown or EGFR T790m was negative, but was treated with osimertinib; 4. Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease; 5. Patients with other malignancies are still receiving treatment, or other malignancies that have recurred or are associated with other malignancies in the past five years, in situ radical treatment of cervical cancer, non-melanoma skin cancer, superficial bladder tumor ( non-invasive tumor ), or carcinoma in situ after radical treatment 3 years without recurrence , no relevant treatment can be considered into the group; 6. Any uncontrollable serious clinical problems (e.g. serious mental, neurological, cardiovascular, respiratory, etc.); 7. The investigators assessed patients as unsuitable for the trial or poor patient compliance with the procedures, limitations, and requirements of the study; 8. Any disease or condition that the researcher considers to be a risk to the patient's safety or to interfere with the study's assessment; 9. Infuse whole blood without white blood cells within 120 days before taking a genetic test sample; 10. Pregnant women who test positive for blood or urine during lactation or screening follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oncogenetic profiling; | — |
Countries
China
Contacts
Public ContactLi Zhang
Cancer Control Center of SUN YAT-SEN University
Outcome results
None listed