Non-small cell lung cancer, NSCLC
Conditions
Interventions
Experimental group:Induction therapy:
Adebelimab 1200 mg, IV, Q3W + pemetrexed 500 mg/m2 (non-squamous carcinoma), D1/nab-paclitaxel 260 mg/m2 (squamous cell carcinoma), D1 + carboplatin AUC5, D1
3 cycles.
sequential/concurrent chemoradiotherapy:
Patients who did not progress after the end of induction therapy (tumor remission reached PR, CR, or SD) were treated with sequential/concurrent chem
Up to 2 cycles, the radiation dose is PTV 54-60Gy/27-30F (primary + lymph nodes).
Consolidation therapy:
After 3 weeks after the end of chemoradiotherapy, the consolidation therapy stage was entered,
Sponsors
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (both ends), male and female; 2. Histologically or cytologically confirmed stage IIIB-IIIC NSCLC; 3. ECOG physical fitness status score 0~1 points; 4. No prior systemic therapy for stage III NSCLC or treatment with immune checkpoint inhibitors; 5. Negative for EGFR/ALK/ROS1; 6. Women of childbearing potential must have a serum pregnancy study within 7 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 contraception for 24 weeks from the time of signing the informed consent form to the last dose of study drug (the recommended contraceptive method refers to protocol 4.3.1); 7. Expected survival time>=12 weeks; 8. Subjects must have at least one measurable lesion by CT or MRI examination in accordance with RECIST1.1 criteria; 9. Before the first dose of study drug, the laboratory test value meets the following conditions: (1) Blood routine (no blood transfusion within 14 days before screening, no correction with hematopoietic stimulating factor drugs): white blood cell count (WBC) >= 3.0×109/L; absolute neutrophil count (ANC) >= 1.5×109/L; platelet (PLT) >=100×109/L; hemoglobin (HGB) >= 9.0g/dL; (2) Liver function: aspartate transferase (AST) =50mL/minute (using the Cockcroft/Gault formula, refer to Annex II); (4) Coagulation function: international normalized ratio (INR) 1.5xULN without clinical or imaging evidence of pancreatitis); Amylase 1.5xULN without clinical or radiologic evidence of pancreatitis); alkalinephosphatase (ALP) <=2.5ULN, liver metastasis or bone metastasis,ALP <=5ULN; 10. The subjects voluntarily participated in this study, signed the informed consent form, with good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Active or symptomatic CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during screening and previous imaging assessments; 2. Spinal cord compression that was not relieved by surgery and/or radiotherapy, or previously diagnosed spinal cord compression that was treated without clinical evidence of stable disease for at least 1 week before study entry; 3. Leptomeningeal disease; 4.EGFR/ALK/ROS1 positivity 5. Clinically symptomatic third space effusion requiring repeated drainage, such as pericardial effusion, pleural effusion and peritoneal effusion that could not be controlled by pumping or other treatments; 6. Uncontrolled or symptomatic hypercalcemia; 7. Other malignant tumors occurred within 5 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical prostatectomy, and ductal carcinoma in situ after radical prostatectomy (hormone therapy for non-metastatic prostate cancer or breast cancer was allowed); 8. Active, known or suspected autoimmune diseases (see Annex IV) include, but are not limited to, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Patients with type I diabetes (glycemic control with insulin therapy), residual hypothyroidism due to autoimmune thyroiditis requiring only hormone-replacement therapy, or no expected recurrence in the absence of external stimuli were allowed. Patients with eczema, psoriasis, lichen simplex, or only skin manifestations of vitiligo (excluding psoriatic arthritis) if the rash covers less than 10% of the body surface area, the disease is adequately controlled at baseline, and only low-potency topical steroids are required. Patients were eligible if they had not had an acute exacerbation of an underlying medical condition (no requirement for psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high-potency, or oral steroids) within the previous 12 months. 9. Any prior T cell costimulation or immune checkpoint therapy, including but not limited to cytotoxicTlymphocyte-associatedantigen-4 (cytotoxicTlymphocyte-associatedantigen-4), CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs targeting T cells; 10. Subjects on systemic treatment with corticosteroids (> 10mg/ day prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug. Inhaled or topical corticosteroids and adrenal-hormone-replacement therapy at a efficacy dose of prednisone of more than 10mg per day were allowed in the absence of active autoimmune disease. 11.HBsAg positive and HBVDNA copy number greater than the upper limit of normal value (1000 copies /ml or 500IU/ml), or HCV positive (HCVRNA or HCVAb test indicates acute or chronic infection); The known history of HIV positive or known acquired immune deficiency syndrome (AcquiredImmuneDeficiencySyndrome, AIDS); 12. A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or clinically active pneumonia; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area can participate in this study); tuberculosis (TB) or a histor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year PFS ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall response rate;Duration of response;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactXu Shuangbing
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed