Lung cancer
Conditions
Interventions
Experimental group:Tirellizumab (200mg) combined with chemotherapy for 3 cycles.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stage III /N2 non-small cell lung cancer with pathologically defined stages and initially inoperable: 1. Patients with initially untreated, unresectable stage III NSCLC (according to the International Association for the Study of Lung Cancer IASLC 8th Thoracic Tumor Stage) with non-small cell lung cancer; All patients received baseline PET/CT (or neck, upper thoracic and abdominal CT+ cranial MR) for clinical staging. 2. Cytology/histology (mediastinoscopy or EBUS, etc.) confirmed N2 non-small cell lung cancer; 3. For non-squamous cell carcinoma patients, if EGFR/ALK mutation status is unknown, tissue samples should be provided for EGFR/ALK gene testing before enrollment; For patients with squamous cell carcinoma, if EGFR/ALK mutation status is unknown, testing is not required during screening. 4.ECOG (Performance status, PS) score 0-1; 5. Hematological tests met: i, neutrophil =1500*109/L; ii. Platelets =100*109/L; iii. Hemoglobin > 9.0g/dL; iv, serum creatinine =1.5*ULN or creatinine clearance (CrCl) =40mL/min; v, AST/ALT=3*ULN; vi, total bilirubin =1.5ULN; vii. FEV1=1.2L or > 40% of the estimated value; viii. INR/APTT within normal range; 6. The patient is over 18 years old; 7. Measurable lesions (according to RECIST1.1 standard); 8. Subject must understand and voluntarily sign informed consent prior to any study-related evaluation.
Exclusion criteria
Exclusion criteria: 1.The patient presents with a confirmed or suspected autoimmune disorder. Note: Patients diagnosed with vitiligo, type I diabetes, or Hashimoto's thyroiditis accompanied by hypothyroidism and undergoing hormone replacement therapy may be eligible for inclusion in the study provided that there are no evident indications of relapse; 2. Patients must have undergone systemic corticosteroid treatment (=10mg prednisolone [or equivalent]/day) or received other immunosuppressive medications within 14 days prior to enrollment. Note: Inhaled or topical corticosteroids and adrenal hormone replacement therapy (=10mg prednisolone [or equivalent]/day) can also be accepted for individuals lacking clear evidence of autoimmune disorders; 3. Patients with grade 3 to 4 interstitial lung disease; 4. Have other malignant tumors and need anti-tumor therapy; 5. Patients with previous malignancies (except skin malignancies other than melanoma, and in situ cancers of the following sites (bladder, stomach, colorectal, endometrial, cervix, melanoma, or breast) were not included in the study. Unless the malignancy has been in complete remission for two years or more and no additional antitumor therapy is required during the study period; 6. The investigator believes that the patient is medically, psychologically, or physically unable to complete the study or to understand the information in the patient manual; 7. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA, and other drugs targeting T-cell co-stimulation or immune regulatory pathways; 8. Active hepatitis B, C, or syphilis; 9.HIV positive or have been diagnosed with acquired immune deficiency disease (AIDS); 10. Allergy to the investigational drug; 11. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response(MPR);Pathologic Complete response(pCR);security;Disease-free survival(DFS); | — |
Countries
China
Contacts
Public ContactXue Hou
Sun Yat-sen University Cancer Center
Outcome results
None listed