lung cancer
Conditions
Interventions
Trail group:NA
Sponsors
the First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age = 18 years old; (2) Advanced, metastatic, or recurrent lung cancer confirmed by histology or cytology as stage IIIB/IIIC/IV, unresectable, and unable to undergo radical synchronous radiotherapy and chemotherapy; (3) The patient is able and willing to provide embedded wax blocks and fresh pathological tissue; (4) Has not received any systematic anti-tumor treatment for advanced/metastatic diseases in the past; For patients who have previously received platinum containing adjuvant chemotherapy, neoadjuvant chemotherapy, or radical radiotherapy and chemotherapy for advanced diseases, if the disease progression occurs more than 6 months after the end of the last treatment, they are eligible to participate in this study; (5) According to RECIST v1 1 standard, recruited subjects have measurable lesions; (6) ECOG performance status is 0 or 1; (7) Expected lifespan>3 months; (8) Within 14 days prior to the first study treatment, patients must have appropriate organ function as defined by the following laboratory results: ? Absolute neutrophil count = 1500/mm ³ ? Platelets = 100000/mm ³ ? Hemoglobin>9 g/dL (blood transfusion allowed) ? Creatinine clearance rate>60 mL/min ? Bilirubin = 1.5X upper limit of normal (ULN) (unless Gilbert syndrome allows 3 X ULN) ? Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5X ULN (unless there is a documented liver metastasis, = 5X ULN is allowed) ? Alkaline phosphatase (ALP) = 2.5X ULN (unless there is a documented bone or liver metastasis, where = 5X ULN is allowed). ? International standardized ratio (INR), prothrombin (PT) and prothrombin time (PTT) = 1.5 X ULN (unless the subject is undergoing anticoagulant therapy) (9) Female participants of childbearing age are required to take effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period; (10) During the study period, patients were willing and able to comply with the study protocol, including treatment and scheduled visits, as well as examinations including follow-up. (11) The patient/guardian voluntarily participated in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: Any of the following criteria must be excluded from this study: Diagnosed with NSCLC with EGFR sensitive mutations or ROS1 and ALK gene rearrangements. (2) Received approved systemic anti-cancer therapy, including hormone therapy, within 28 days prior to initiating the study treatment. (3) Previously received EGFR inhibitors or ALK inhibitors. (4) Previously received treatment targeting PD-1 or PD-L1. (5) Received systemic immune modulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) within 4 weeks prior to randomization or within 5 half lives of the drug (whichever is longer) (previous cancer vaccination is allowed). (6) He had received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations for cancer control within 14 days before randomization. (7) Have a history of interstitial lung disease, non infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc. (8) Severe pericardial effusion in clinical practice. (9) Within the first 2 weeks of randomization, there were clinically uncontrolled pleural effusion or ascites that required thoracentesis or abdominal incision for drainage. (10) Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. (11) Active leptomeningeal disease or uncontrolled and untreated brain metastases; Patients with a history of asymptomatic CNS metastases can be selected as long as they meet all of the following criteria: The brain imaging during screening showed no evidence of immediate progression. If there are measurable diseases outside the CNS, only supratentorial metastasis is allowed. Currently, there is no need to use glucocorticoids to treat CNS diseases; Allow the use of stable doses of anticonvulsants. No stereotactic or whole brain radiation therapy was performed within the 14 days prior to randomization. Patients who discover new asymptomatic CNS metastases during screening must undergo radiotherapy and/or surgery to treat CNS metastases. After treatment, these patients can be included as long as they meet all other criteria, including those for patients with a history of brain metastases. (12) Have undergone any major surgery within = 28 days prior to randomization. (13) Prior to randomization, acute effects caused by previous treatments (such as adjuvant chemotherapy) still existed and exceeded CTCAE1 grade (except for hair loss that is unlikely to pose a safety risk). (14) Within 6 months prior to the first administration of the study treatment, lung lesions received radiation therapy exceeding 30 Gy (excluding radiation therapy for other lesions). (15) There is any active malignant tumor within = 2 years before randomization, except for the specific cancer being studied in this trial and the locally recurrent cancer that has been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer cancer, cervical cancer in situ or breast cancer). (16) Known human immunodeficiency virus infection. (17) Untreated chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA exceeding 500IU/mL, or active hepatitis C virus (HCV) infection patients should be excluded. Note: Non active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA<500 IU/mL), and cured hepatitis C patients can be included in the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Second generation transcriptome sequencing of gut microbiota;Third generation transcriptome sequencing of gut microbiota; | — |
Countries
China
Contacts
Public ContactKAI CHEN
the First Affiliated Hospital of Soochow University
Outcome results
None listed