Lung Cancer
Conditions
Interventions
A:PD-1 antibody+cytokine inhibitor
B:PD-1 antibody+epigenetic inhibitor
C:PD-1 antibody+anti-angiogenesis
D:chemotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the research and sign the informed consent form; 2. The researcher judges that he can comply with the research plan; 3. Subjects aged 18-70 years old when they sign the informed consent form, both male and female; 4. Subjects who are diagnosed as non-squamous carcinoma non-small cell lung cancer (NSCLC) by histology or cytology and are stage IIIB-IV tumors (according to the 8th edition of the Joint Committee on Cancer Staging Manual); 5. The research center must be able to provide relevant documents about the subject's EGFR mutation and ALK fusion gene status, and they must all be negative. Subjects cannot be randomized into the group before the EGFR mutation and ALK fusion gene status recorded in the source files of the research center; 6. Subjects have previously received systemic platinum-containing dual-drug chemotherapy for advanced/metastatic NSCLC and immune monotherapy with PD-1/PD-L1 inhibitors, or PD-1/PD-L1 inhibitors Combination therapy with platinum-containing dual-drug chemotherapy has failed or recurred; 7. Tumor tissue specimens archived at the time of diagnosis of advanced or metastatic tumors and within 6 months before the first administration must be provided, as well as archived or freshly obtained after the end of front-line treatment, formalin-fixed, paraffin-embedded Tumor tissue mass after embedding (FFPE). The tissue block provided should be able to cut at least 10 slices for staining and testing (if approved by the sponsors medical supervisor, less than 10 slices can be provided). Fine-needle aspiration biopsy specimens, pleural effusion drainage and centrifugal cell smears, or drill biopsy are not sufficient for biomarker detection. Bone lesions without soft tissue components or decalcified bone tumor specimens are also unacceptable; 8. According to the RECIST 1.1 standard, subjects must have measurable target lesions that can be examined by CT or MRI. Tumor imaging evaluation was performed within 28 days before the first medication. Subjects need to provide historical imaging examination results for comparison to determine the presence of PD during frontline treatment. 9. ECOG PS score 0-1 points; 10. The expected survival period >=3 months; 11. Perform all laboratory tests during the screening period in accordance with the requirements of the protocol, and must be performed within 14 days before the first medication. The values of laboratory tests performed by screening must meet the following criteria: (1) Routine blood examination: (No blood transfusion, no use of G-CSF, no correction with medication within 14 days before screening): Hemoglobin (HB) >=90g/L; The absolute value of neutrophil count (ANC) >=1.5x10^9/L; Platelet count (PLT) >=100x10^9/L; White blood cell count (WBC)>=4.0x10^9/L and =30 g/L; Cr=60 mL/min (Cockcroft-Gault formula); urine protein =2+, additional 24-hour urine protein quantification is required, 24 Subjects whose hourly urine protein quantification is less than 1g can be included in the study); APTT<=1.5 ULN, while INR or PT<=1.5 ULN (not receiving anticoagulation therapy); (3) Cardiac color Doppler ultrasound
Exclusion criteria
Exclusion criteria: Target disease exclusion criteria: 1. with other histopathological types of non-small cell lung cancer, including subjects with mixed squamous carcinoma, subjects with NSCLC containing small cell lung cancer, and neuroendocrine cancer; 2. EGFR mutation or ALK fusion positive subjects; 3. without measurable lesions. 4. with cancerous meningitis, spinal cord compression, etc.; 5. with untreated central nervous system (CNS) tumor metastases. If the subject's CNS tumor metastasis is limited to the supratentorial and/or cerebellum and has received adequate treatment, such as clinical stability (imaging testing, enhanced MRI or CT is preferred) has been maintained for at least 4 weeks, and the subject's nervous system If the clinical symptoms can be restored to NCI-CTC AE 10 mg/day prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 14 days before the first medication. In the absence of active autoimmune diseases, inhaled or topical corticosteroids are allowed, as well as adrenal hormone replacement therapy with a dose> 10 mg/day of prednisone; 3) Exclude subjects who have been treated with anti-tumor vaccines or other immune-stimulating anti-tumor drugs (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before the first medication. 4) Exclude subjects who are participating in other clinical studies or whose first medication is less than 4 weeks from the end of the previous clinical study (last medication) (or 5 half-lives of the study drug); 5) Exclude subjects who are expected to require any other form of anti-tumor therapy (including maintenance therapy with other NSCLC drugs, radiotherapy, and/or surgical resection) in the study; 6) Exclude those who underwent major surgery within 4 weeks before the first medication, those with non-thoracic radiation therapy >30 Gy within 4 weeks before the first medication, those with chest radiation >30 Gy within 24 weeks before the first medication, and 2 before the first medication Subjects who received palliative radiation =30 Gy within a week and who failed to recover from the toxicity and/or complications of these interventions to NCI-CTC AE <=1 (except for hair loss and fatigue). Palliative radiotherapy for symptom control is permitted and must be completed at least 2 weeks before the start of treatment with the study drug, and there are no plans for additional radiothe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactShengxiang Ren
Shanghai Pulmonary Hospital
Outcome results
None listed