non-small cell lung cancer
Conditions
Interventions
primary resistance group vs.acquired resistance group:Nil
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Able to provide written informed consent, and understand and agree to follow the research requirements; (2) Males or females who are older than 18 years old when signing the ICF; (3) The histopathological diagnosis is advanced stage (stage IV) non-small cell lung cancer except for neuroendocrine cancer; (4) Patients receiving immune checkpoint inhibitor treatment represented by anti-PD-1/PD-L1 monoclonal antibody; (5) Specimen type: The patient must be able to provide fresh tumor tissue before/after immunotherapy (50mg of tumor tissue sample/ 2 needles of 18G thick needle) or tumor tissue archived within one year (FFPE tissue block or about 15 pieces [10- 15 sheets] Freshly cut, unstained FFPE glass slides) and pathology reports (except advanced neuroendocrine NSCLC); provide matched 10mL peripheral whole blood samples at the same time; (6) ECOG physical status = 12 weeks; the patient must have adequate organ function, and the following laboratory test values must be achieved within 7 days before treatment: (A) Absolute neutrophil count (ANC) >= 1.5x10^9/L, platelets >= 100x10^9/L, hemoglobin >= 90g/L; Remarks: The patient must not receive blood transfusion or growth factor support within 14 days before blood sample collection; (B) International normalized ratio (INR) or prothrombin time <= 1.5x ULN; (C) Activated partial thromboplastin time (aPTT)<= 1.5x ULN; (D) Serum total bilirubin <= 1.5x ULN (Patients with Gilbert syndrome can be included if total bilirubin < 3x ULN); (E) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5x ULN. If the patient has liver metastases, this standard is AST and ALT <= 5x ULN.
Exclusion criteria
Exclusion criteria: (1) Patients with other tumors. NOTE: Subjects except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ who have received potential radical treatment and have not relapsed within 5 years before the start of treatment can be included in the study; (2) Have received any approved systemic anti-tumor immunotherapy before starting the research treatment; (3) A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.; (4) Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection; (5) Known human immunodeficiency virus infection; previous allogeneic stem cell transplantation or organ transplantation; (6) The investigator judged that the patient's compliance during the study period was insufficient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS; | — |
Countries
China
Contacts
Public ContactNiu Xiaomin
Shanghai Chest Hospital
Outcome results
None listed