Resectable, driver gene-negative stage IIB-IIIB non-small cell lung cancer
Conditions
Interventions
Test group:Eligible patients will undergo a neoadjuvant regimen of stereotactic body radiotherapy (SBRT) immediately followed by immunotherapy: the gross tumour volume (GTV), contoured on fused 18F-FD
immunotherapy with apaloritovorilimab 5 mg kg?1 is initiated within seven days after SBRT and administered intravenously every three weeks for two cycles. Post-operatively, the same dose and schedule
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation with signed informed consent. 2. Age 18–75 years, regardless of gender. 3. Histologically or cytologically confirmed, untreated, resectable stage IIB-IIIB (T1-3N1-2) NSCLC, irrespective of PD-L1 expression status. 4. EGFR, ALK, and ROS1 wild-type (Patients with other driver mutations are eligible if no approved targeted therapy exists or if they refuse targeted treatment) 5. At least one measurable lesion per RECIST 1.1 criteria. 6. ECOG performance status 0–1. 7. No prior antitumor therapy (including chemotherapy, immunotherapy, or targeted therapy). 8. Life expectancy >3 months. 9. Willingness to provide 10 mL of fasting peripheral blood at specified time points (per study protocol). 10. Adequate organ and bone marrow function: Hematology: a) Hemoglobin (HGB) >=90 g/L b) Absolute neutrophil count (ANC) >=1.5 × 10?/L c) Platelet count (PLT) >=100 × 10?/L Biochemistry: d) AST/ALT =45 mL/min (Cockcroft-Gault formula) g) APTT =1.2 L or >40% of predicted value 11. Contraception requirements: Women of childbearing potential must have a negative pregnancy test (serum/urine) within 14 days before enrollment and agree to use effective contraception during the study and for 180 days after the last dose. Men must be surgically sterile or agree to use effective contraception during the study and for 180 days after the last dose. 12. Willing and able to comply with follow-up until death, study completion, or study termination.
Exclusion criteria
Exclusion criteria: 1. Prior systemic anti-tumor therapy for NSCLC, including cytotoxic drugs, immunotherapy, or experimental treatments. 2. History of thoracic radiotherapy. 3. oncurrent malignancies diagnosed within =10 mg prednisone [or equivalent] daily) or other immunosuppressants within 14 days before the first dose of Iparomlimab and Tuvonralimab Injection. Note: Inhaled/topical steroids or physiologic steroid replacement (e.g., for adrenal insufficiency) is permitted. 7. HIV-positive or AIDS diagnosis. 8. Active hepatitis B (HBV) or hepatitis C (HCV) infection. (Chronic HBV/HCV with controlled viral load may be considered per investigator judgment). 9. Active bleeding before treatment. 10. Interstitial lung disease (ILD) or non-infectious pneumonitis. 11. Severe cardiac, pulmonary, hepatic, or renal dysfunction. 12. Severe active infection within 4 weeks before treatment (requiring IV antibiotics/antivirals/antifungals) or unexplained fever >38.5°C during screening/first dose. 13. Known hypersensitivity to any component of the study treatment. 14. Pregnancy or lactation. 15. History of drug abuse or psychiatric disorders compromising compliance. 16. Other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response, MPR;Pathological Complete Response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival, EFS;Disease-Free Survival, DFS;R0 resection rate;Safety; | — |
Countries
China
Contacts
Public ContactMeng Xue
Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer Hospital)
Outcome results
None listed