Resectable stage IB-IIIA non-small cell lung cancer (NSCLC)
Conditions
Interventions
Treatment group:tislelizumab combined with thoracic radiotherapy
Sponsors
Northern Jiangsu People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand this study and voluntarily sign the informed consent form (ICF). 2. Age 18-70 years, any gender. 3. Histologically confirmed resectable NSCLC at stages IB-IIIA (AJCC 9th edition) without prior treatment; for mediastinal lymph node metastasis (N2): single-station metastasis must be confirmed by imaging or pathology with a short diameter =1500/µL; platelets >=100,000/µL; hemoglobin >=10.0 g/dL; (2) Kidney: serum creatinine =60 mL/min (Cockcroft-Gault formula); (3) Liver: total bilirubin 1.5×ULN, direct bilirubin is normal; AST (SGOT) and ALT (SGPT) <=2.5×ULN; (4) Endocrine: TSH within normal limits. Note: if baseline TSH is out of range but T3 and free T4 are normal, the subject can still be eligible; (5) Coagulation: INR or PT, aPTT <=1.5×ULN. 9. Subject must be willing and able to comply with study visit schedule, treatment plan, lab tests, and other study procedures. 10. Surgical assessment shows lung function adequate to tolerate planned pulmonary resection. 11. Women of childbearing potential must have a negative serum pregnancy test within 3 days before first dose. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use effective contraception during the study and for 180 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Presence of locally advanced unresectable or metastatic disease. 2. NSCLC involving the upper sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors. 3. Participants with known EGFR mutations or ALK rearrangements; non-squamous participants need to have confirmed EGFR and ALK mutation status. 4. Early-stage NSCLC that has previously received systemic anticancer treatment, including investigational drugs. 5. Contraindication to radiation therapy or inability to undergo radiation therapy. 6. History of non-infectious pneumonia/interstitial lung disease requiring steroid treatment, or current pneumonia/interstitial lung disease requiring steroid treatment. 7. Known history of active tuberculosis. 8. Known active infections requiring systemic treatment. 9. Any known or suspected autoimmune disease or immune deficiency, except for: patients with a history of hypothyroidism who don’t need hormone therapy, or are on physiological dose hormone replacement therapy; participants with stable type 1 diabetes with controlled blood sugar. 10. Active Hepatitis B (defined as screening period HBsAg positive with HBV-DNA above the upper normal limit of the local lab) or Hepatitis C (defined as screening period HCV antibody positive and HCV-RNA positive). 11. Known HIV infection (antibody positive). 12. Vaccination with live vaccines within 30 days prior to first dose. This includes but is not limited to: mumps, rubella, measles, varicella/zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines (inactivated vaccines are allowed). 13. Peripheral neuropathy of grade 2 or higher. 14. Previous treatment with PD-1/PD-L1 drugs or other drugs targeting T cell receptors (e.g., CTLA-4, OX-40). 15. Severe hypersensitivity to other monoclonal antibodies. 16. Known serious or uncontrolled underlying disease. 17. Any condition, treatment, or lab abnormality that, in the investigator’s opinion, might confuse trial results, interfere with full participation, or is not in the best interest of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1year EFS Rate;Major pathological response rate; | — |
Countries
China
Contacts
Public ContactBuhai Wang
Northern Jiangsu People's Hospital
Outcome results
None listed