Lung cancer
Conditions
Interventions
Sponsors
Huai'an First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. age 18-75 years, both sexes; 2. histologically or cytologically confirmed stage III nonsectable NSCLC (AJCC 8th edition); 3. life expectancy of more than 3 months; 4. ECOG physical status score of 0 to 1; 5. no prior antitumor therapy; 6. women of childbearing potential must have had a negative serum pregnancy study within 7 days prior to first dose. Female subjects of childbearing potential and male subjects whose partner is a woman of childbearing potential must agree to use contraception from the time of signing the informed consent until 24 weeks after the last administration of study drug; 7. Laboratory test values meet the following conditions: (1) blood test (no blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening): white blood cell (WBC) >= 3.0 × 10^9/L; absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet (ANC) >= 1.5 × 10^9/L; hemoglobin (HGB) >= 9.0 g/dL; (2) Liver function: aspartate transferase (AST) = 1.5 x ULN. alanine aminotransferase (ALT) = 50 mL/minute; (4) Coagulation function: international normalized ratio (INR) 1.5 x ULN without clinical or imaging results). ULN without clinical or imaging confirmation of pancreatitis can be enrolled); amylase 1.5 x ULN without clinical or imaging confirmation of pancreatitis can be enrolled); alkaline phosphatase (ALP) <= 2.5 x ULN, and ALP <= 5 x ULN for subjects with liver or bone metastases; 8. Subjects will voluntarily enroll in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. histologically or cytologically confirmed mixed SCLC and NSCLC, large cell neuroendocrine carcinoma and sarcomatoid carcinoma; 2. presence of malignant pleural effusion. If a patient has an extractable pleural effusion during screening, at least one thoracentesis must be performed to confirm the presence of malignant cells; 3. pregnant and lactating women; 4. previous systemic chemotherapy; 5. hormonal cancer therapy or radiation therapy within 5 years prior to enrollment (those who have had surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignant neoplasm more than 5 years prior to enrollment. However, those who are currently considered cured are acceptable. Current use of hormone replacement therapy or oral contraceptives is permitted). 6. patients with hearing impairment; 7. known hypersensitivity to any component of the chemotherapy regimen the patient will receive or to mannitol; 8. interstitial lung disease or a history of pneumonia; 9. malignancies other than NSCLC that have occurred within 5 years prior to enrollment, with the exception of those who have had a minimal risk of metastasis or death (e.g., an expected 5-year survival rate of greater than 90%) and who have achieved the expected cure with treatment (e.g., adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer treated to curative intent, and ductal carcinoma in situ treated to curative intent). 10. Active, known or suspected autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus rheumatoid arthritis, and inflammatory bowel disease. Enrollment is allowed for type I diabetes mellitus (glycemic control with insulin therapy), residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or lack of exogenous stimuli that are not expected to recur; 10. patients with eczema, psoriasis, chronic lichen simplex moss, or vitiligo dermatologic manifestations only (psoriatic arthritis needs to be ruled out) may be enrolled if the rash Cover less than 10% of the body surface area, have adequately controlled disease at baseline and require only low-potency topical steroid therapy, and have not had an acute exacerbation of the underlying disease in the past 12 months (do not require psoralens plus ultraviolet radiation [PUVA], aminoglutethimide, retinoids, biologics, oral calmodulin phosphatase inhibitors, high potency, or oral steroids) may be enrolled in the study; 11. Have received prior Any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs that target T cells; 12. HBsAg Positive and HBV DNA copy number greater than the upper limit of normal values (1000 copies/ml or 500 IU/ml) in the laboratory of the research center, or HCV positive (HCV RNA or HCV Ab test suggestive of acute or chronic infection); 2.known history of HIV-positive disease or known Acquired Immune Deficiency Syndrome (AIDS); 13. History of idiopathic pulmonary fibrosis, organic pneumonia (e.g., occlusive bronchiolitis), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or active pneumonitis with clinical symptoms; 3.or other moderate-to-severe lung disease that severely affects lung function (patients with a history of radiation pneumonitis (fibrosis) in the rad
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 18-month EFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;TTDM;OS;MPR;EFS; | — |
Countries
China
Contacts
Public ContactYu changhua
Huai'an First People's Hospital
Outcome results
None listed