Lung Cancer
Conditions
Interventions
Intervention group:Tislelizumab 400 mg iv, q6w, for up to 1 year
patients are permitted to receive concurrent adjuvant platinum-based doublet chemotherapy (q3w, up to 4 cycles) starting from the first dose of tislelizumab
during concurrent chemotherapy, a tislelizumab dosage of 200 mg iv, q3w is allowed.
Control group:Patients are permitted to receive postoperative adjuvant platinum - based doublet chemotherapy (q3w, up to 4 cycles).
Sponsors
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent form (ICF) and agree to follow study requirements and assessment schedule. 2. Aged 18 years or older. 3. Histologically confirmed stage I non - small cell lung cancer (AJCC 9th edition), with tumor size 2cm =20%, including solid, micropapillary, or complex glands)). 5. ECOG performance status 0 or 1. 6. PD-L1 expression >=1%. 7. No EGFR/ALK sensitive mutations. 8. Achieved complete resection (R0) ; 9. Within 8 weeks after surgery, with full recovery from operation. 10. Adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Any previous treatment for current lung cancer, including radiotherapy and systemic anti-tumour therapies (chemotherapy, immunotherapy, targeted therapy, anti-angiogenesis therapy, etc.). 2. Prior chest radiotherapy (including lung, oesophageal, mediastinal, or breast cancer). 3. Patients with large - cell neuroendocrine carcinoma (LCNEC) or mixed - subtype non - small - cell lung cancer with small - cell components. 4. With EGFR/ALK sensitive mutations. 5. Underwent segmentectomy or wedge resection only. 6. Tumours involving main bronchi, or with obstructive pneumonia/atelectasis (partial or whole lung). 7. Active autoimmune disease or history of relapsing autoimmune disease. 8. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis needing hormone therapy, or current active interstitial lung disease, or on relevant treatment/intervention. 9. Any condition needing systemic corticosteroid (> 10 mg/d prednisone or equivalent) or other immunosuppressant within 14 days before randomisation 10. Used other approved systemic immunomodulators (interferon, interleukin - 2, tumour necrosis factor, thymopentin, thymosin a1, etc.) within 4 weeks before first dose. 11. Herbs used for cancer control within 14 days before first study 12. Live/attenuated vaccine receipt within 4 weeks before enrollment, or plan to receive during study or within 5 months after last tislelizumab dose. 13. History of significant disease or conditions affecting organ/system function, per investigator’s judgment. 14. Severe chronic/active infection needing systemic antibacterial, antifungal, or antiviral therapy (e.g., tuberculosis) within 14 days before first study-drug dose. 15. Known HIV infection. 16. Allogeneic stem - cell/organ transplant history. 17. Active malignancy within 2 years before enrollment, except the specific cancer studied and locally recurrent cancers cured (e.g., excised basal/squamous - cell skin cancer, superficial bladder cancer, cervical/ breast carcinoma in situ). 18. Specific conditions and/or alcohol/drug abuse or dependence that may hinder drug administration, affect outcome interpretation, or increase complication risks. 19. Pregnant/breastfeeding women, or men/women planning to conceive during the study. 20. Participation in another interventional clinical study (except observational studies or follow-up phases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year disease-free survival rate, 2y-DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival, DFS;overall survival, OS;time to distant metastasis, TTDM;time to locoregional recurrence, TTLR;Safety; | — |
Countries
China
Contacts
Public ContactTan Fengwei
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed