Lung cancer
Conditions
Interventions
Research group:Neoadjuvant therapy
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have a full understanding of this research and voluntarily sign the Informed Consent Form (ICF); 2. The age is 18 to 70 years old, and the gender is not limited; 3. Potentially operable stage IIIB (T3-4N2) (AJCC staging eighth edition) NSCLC confirmed by histology and confirmed by multidisciplinary discussions without prior treatment; cTNM staging can be confirmed by PET-CT or pathological biopsy; 4. According to the solid tumor efficacy evaluation standard version 1.1, there are measurable lesions; 5. Submit tumor tissue samples for pathological diagnosis, PD-L1 expression and biomarker detection (tumor tissue samples must be fresh or archived samples obtained within 3 months before enrollment; tumor tissue samples must be histological Scope samples, including but not limited to thick needle, hollow needle puncture tissue, bronchoscope clamp to obtain tissue, surgical resection samples; fine needle aspiration, bronchial brushing to obtain samples potentially acceptable); 6. ECOG score 0-1; 7. Good organ function: 8. Hematology: absolute neutrophil count (ANC) >=1500/uL; platelets >=100000/uL; hemoglobin >=9.0g/dL or >=5.6 mmol/L; 9. Kidney: Serum creatinine = 60 mL/min (using Cock-Gault formula); 10. Liver: total bilirubin 1.5*ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT) <= 2.5*ULN; 11. Endocrine system: Thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within the normal range at baseline, and if T3 and free T4 are within the normal range, the patient may still meet the inclusion criteria; 12. Coagulation function: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) <= 1.5*ULN, except patients receiving anticoagulation therapy, as long as PT or aPTT within the intended range of use of anticoagulant drugs; 13. Willing and able to comply with the visit, treatment plan, laboratory examination, and other research procedures of the research plan; 14. Women of childbearing age must take a serum pregnancy test within 3 days before the first dose, and the result is negative. Female patients of childbearing age and male patients with partners of childbearing age 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. NSCLC, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumor involving the superior sulcus; 2. NSCLC who have received systemic anticancer therapy in the past, including experimental drug therapy; 3. A history of (non-infectious) pneumonitis/interstitial lung disease requiring steroid therapy, or current pneumonia/interstitial lung disease requiring steroid therapy; 4. Known history of active tuberculosis; 5. Known to have active infection requiring systemic treatment; 6. Patients with any known or suspected autoimmune disease or immunodeficiency, except patients with a history of hypothyroidism, if no hormone therapy is required, or are receiving physiological doses of hormone replacement therapy; stable type I diabetes mellitus with controlled blood sugar patient; 7. Uncontrolled active hepatitis B (defined as a positive hepatitis B virus surface antigen [HBsAg] test result during the screening period and an HBV-DNA test value higher than the upper limit of the normal value of the laboratory department of the research center; (Patients with an HBV-DNA content =2; 11. Previous treatment with PD-1/PD-L1 drugs or treatment with another drug that targets T cell receptors (such as CTLA-4, OX-40, etc.); 12. Severe allergic reactions to other monoclonal antibodies; 13. Have a history of severe allergy to pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin or its preventive medicine; 14. Known to have serious or uncontrolled underlying diseases; including but not limited to hemodynamically unstable cardiovascular events within 6 months, symptomatic cerebrovascular events, liver disease with Child-Pugh A grade or above hardening; 15. According to the judgment of the investigator, the patient has a history or current evidence of any disease, treatment or laboratory abnormality that may confuse the test results, interfere with the patient's participation in the whole trial or not in the best interests of the patient to participate in the trial; 16. Suffering from other malignancies other than small cell lung cancer within 5 years before the first drug. Malignant tumors with negligible risk of metastasis or death (eg, expected disease-free survival >5 years) and expected curative outcome after treatment (eg, adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, curative In situ ductal carcinoma treated by purpose) can be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stage III B median overall survival (OS);Event-free survival (EFS) assessed by investigators in the Stage III B population;Lymph node descending rate;Stage III B population, investigator-assessed MPR rate;2 - and 3-year overall survival in stage III and B populations; | — |
Countries
China
Contacts
Public ContactQingquan Luo
Shanghai Chest Hospital
Outcome results
None listed