Lung Cancer
Conditions
Interventions
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subject's written informed consent has been obtained prior to any process, sampling, or analysis related to the study; 2. Male or female is not limited, and the age is not less than 18 years old (on the day of signing the informed consent form); 3. The patient was diagnosed as NSCLC by histology or cytology; 4. The tumor is locally advanced or metastatic NSCLC and is not suitable for radical surgery or radiotherapy 5. At least with one evaluable lesion; 6. There is enough tissue sample (e.g. FFPE sample) for molecular detection and confirmation. 7. Previously untreated with first-line systemic anti-tumor treatment, including any kinds of PD-1/PD-L1 inhibitorsTreatments used in neo-adjuvant setting are not includedPostoperative adjuvant chemotherapy, if the date of last dose to recurrence is beyond 6 months, then is not included. 8. ECOG PS score 0~1 points, expected survival period >= 12 weeks; 9. Patients who voluntarily accept plasma-based NGS molecular detection. 10. Female subjects and partners who are women of childbearing age should be sterilized or must agree to use high-efficiency methods during the study period and within 6 month after the end of the study period. Female subjects of childbearing age must have a negative serum HCG test within 7 days prior to study enrollment and must be non-lactating subjects.
Exclusion criteria
Exclusion criteria: 1. Any other study drug was used within 4 weeks prior to enrollment; 2. Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks prior to the first dose, or unexplained fever >38.5 degree C during screening/first administration; 3. History of allogeneic organ transplantation or history of allogeneic hematopoietic stem cell transplantation; 4. Have had or have other systemic malignancies in the last 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ and ovarian cancer); 5. Pregnant, lactating women, reproductively motivated subjects are reluctant to take effective contraceptive measures; 6. Suffering from mental disorders that are difficult to control; 7. Other circumstances that the investigator believes are not suitable for inclusion. For example, patients with central nervous system metastases, severe laboratory abnormalities, with family or social factors, may affect the safety of the subject, or the collection of data and samples.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Repeatability;Lowest detection limit;Objective response rate;12-month progression-free survival rate;Progression-free survival;Disease control rate; | — |
Primary
| Measure | Time frame |
|---|---|
| agreement rate;positive corresponding rate;negative corresponding rate; | — |
Countries
China
Contacts
Public ContactShengxiang Ren
Shanghai Pulmonary Hospital
Outcome results
None listed