Non- Small Cell Lung Cancer
Conditions
Interventions
A:Sintilimab Injection
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Have fully understood this study and voluntarily signed the informed consent form (ICF); 2.Age 18 - 75 years old, regardless of gender; 3.Advanced or recurrent stage III B-C or IV non-squamous or non-small cell lung cancer confirmed by histology and/or cytology (According to the AJCC staging system, version 8) with sensitive EGFR mutations and meeting the following conditions: 1) After treatment failure with first or second-generation EGFR-TKI (Including gefitinib, erlotinib, icotinib, afatinib, etc), the patient's genetic test showed no T790M mutation in exon 20 after re-biopsy; 2) After treatment failure with first or second-generation EGFR-TKI single agent (Including gefitinib, erlotinib, icotinib, afatinib, etc), the patient's genetic test after re-biopsy developed a T790M mutation in exon 20, and then developed disease progression again after receiving osimertinib or other three-generation EGFR-TKIs; 3) Participants who had failed previous osimertinib or other three-generation EGFR-TKIs as first-line treatment met the inclusion criteria (regardless of their EGFR T790M mutation status). 4) Premature neoadjuvant/adjuvant chemotherapy is allowed, and disease recurrence or metastasis occurs more than 6 months after the last dose of chemotherapy is completed; 4.At least one measurable lesion (according to RECIST 1.1); 5.If you agree to provide previously stored tumor tissue specimens after failed EGFR-TKI treatment or freshly biopsied tumor lesion tissue, relevant pathology reports of the above specimens must be provided. PD-L1 test results must be available for tissue after re-biopsy; 6.Performance status score of 0 or 1 according to Eastern Cooperative Oncology Group (ECOG) criteria; 7.Expected survival time >=3 months; 8.Adequate hematological function (no blood transfusion, no G-CSF use, no medication correction within 14 days before screening): Hemoglobin (HB) >=90g/L; absolute neutrophil count (ANC) >=1.5×10^9/L; platelet count (PLT) >=100×10^9/L; white blood cell count (WBC) >=4.0×10^9/L or the lower limit of normal for this study site, and =30g/L; 10.Adequate renal function: Cr=60 mL/min (cisplatin) or CrCL>=50 mL/min (carboplatin)(Cockcroft-Gault formula); 11.Adequate coagulation function: APTT<=1.5×ULN, and INR or PT<=1.5×ULN (not receiving anticoagulant therapy); 12.Any adverse event caused by previous treatment, surgery, or radiotherapy must have resolved to Grade 0 or 1 (except for hair loss of any grade according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0); 13.Willing and able to comply with planned visits, treatment plans, laboratory tests and other study procedures; 14.Women of childbearing age must take a serum pregnancy test within 3 days before the first dose and the result is negative. Female subjects of childbearing potential and male subjects whose partner is a woman of childbearing potential must agree to use a highly effective method of contraception during the study and for 180 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1.Patients are diagnosed with squamous cell carcinoma, mixed adeno-scale or combined small cell lung cancer components confirmed by tumor histology or cytology; 2.Genetic testing of the patient's pathological tissue combined with other driver gene mutations with known drug treatments, including but not limited to: ALK gene rearrangement, ROS1 mutation, and BRAF600E mutation; 3.The patient had previously received systemic chemotherapy for advanced NSCLC; 4.Excluding subjects with no measurable lesions; 5.Subjects with cancerous meningitis, spinal cord compression, etc. No clear surgery and/or radiotherapy was performed for spinal cord compression, or for previously diagnosed and treated spinal cord compression, there was no evidence that the disease was clinically stable for >=2 weeks prior to randomization; 6.Subjects with untreated central nervous system (CNS) tumors that have metastasized. Subjects may participate in the study if their CNS tumor metastases are limited to the supratentorial and/or cerebellum, have received adequate treatment (radiotherapy or surgery for CNS metastases) and maintained clinical stability (imaging detection, preferred enhanced MRI or CT) for at least 4 weeks, and the subjects 'nervous system and other clinical symptoms can recover to NCI-CTCAE<=1 at least 2 weeks before the first dose. If a patient is found to have new asymptomatic CNS metastases during the screening scan, he must undergo radiotherapy or/and surgery for the CNS metastases. In addition, subjects who use corticosteroids to treat relevant clinical symptoms cannot participate in the study if they receive a stable or gradually decreasing dose of prednisone (or equivalent) <=10 mg/day for at least 2 weeks, otherwise they cannot be enrolled; 7.Previous treatment against the PD-1 receptor or its ligand PD-L1 or the cytotoxic T lymphocyte associated protein 4 (CTLA-4) receptor; 8.The patient's tumor compresses important surrounding organs (such as esophagus) and is accompanied by related symptoms, compresses the superior vena cava or invades the mediastinal great vessels, heart, etc.; 9.The patient had any arterial thrombosis, embolism or ischemia within 6 months before being enrolled in treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months prior to enrollment (thrombosis from implanted venous access port or catheter origin, or superficial venous thrombosis is not considered "serious" thromboembolism); 10.Subjects with any active, known or suspected autoimmune disease were excluded. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; 11.Subjects who required systemic treatment with corticosteroids (10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before the first dose were excluded. In the absence of active autoimmune disease, inhaled or topical corticosteroids, as well as adrenal hormone replacement therapy at doses =10 mg/day, effective doses of prednisone are allowed; 12.Excluding subjects who have been treated with anti-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month progression-free survival rate;disease control rate, DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;overall survival, OS;objective response rate, ORR;duration of response, DOR;18-month progression-free survival rate;safety; | — |
Countries
China
Contacts
Public ContactJie Zhang
Shanghai Pulmonary Hospital
Outcome results
None listed