non-small-cell lung cancer
Conditions
Interventions
experimental group:Neoadjuvant chemotherapy and Tilelizumab
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Untreated and histologically confirmed stage III (T2N2, T3-4N1-2) NSCLC (as defined by the American Joint Committee on Cancer 8th Edition); 2. If the driver gene negative for EGFR sensitive mutations and ALK and ROS1 gene fusion mutations has not been detected before, test specimen tissue/blood; 3. Tumor assessment scan using (CT) and (PET-CT) or magnetic resonance (MRI); 4. The date of signing the informed consent is >= 18 years old and <= 65 years old; 5. Eastern Cooperative Oncology Group (ECOG) physical status is 0 or 1; 6. Have measurable diseases assessed by the investigator according to RECIST Version 1.1; 7. After neoadjuvant treatment, the MDT team and the chief surgeon comprehensively assessed and confirmed that they meet the requirements for radical resection; 8. After neoadjuvant therapy, evaluate once every 2 cycles. For PD, discontinue tislelizumab and receive simultaneous radiotherapy. PR/SD patients will discuss MDT and adopt surgical treatment; 9. Good cardiopulmonary function, able to tolerate surgery; 10. Eligible to receive platinum-containing dual-drug chemotherapy; 11. Can provide representative pre-treatment tumor tissue samples/peripheral blood samples for biomarker analysis.
Exclusion criteria
Exclusion criteria: 1. Have received any treatment for the current lung cancer, including chemotherapy or radiotherapy; 2. Patients with positive driver genes are known to carry EGFR mutations or ALK, ROS1 gene translocations; 3. After neoadjuvant treatment, pneumonectomy is still required at the last evaluation; 4. Suffered from any disease requiring systemic treatment with corticosteroids (daily dose of prednisone or equivalent drugs> 10 mg) or other immunosuppressive drugs in the 14 days before enrollment; Adrenaline replacement steroids (daily doses > 10 mg of prednisone or equivalent) are allowed for topical, ocular, intra-articular, intranasal or inhaled corticosteroids, and minimum systemic absorption is required, and they are prescribed Corticosteroids are short-term (= 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA <500 IU/mL), and cured hepatitis C patients can be included in the group. 11. If any major surgery requiring general anesthesia has been performed <= 28 days before randomization. 12. Previous allogeneic stem cell transplantation or organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0; | — |
Countries
China
Contacts
Public ContactZhou qing hua
West China Hospital, Sichuan University
Outcome results
None listed