NSCLC
Conditions
Interventions
single-arm:Tislelizumab 200mg Q3W + chemotherapy for 4 cycles and followed by Tislelizumab 200mg Q3W Up to 10 cycles or until PD or intolerable toxicity or withdraw.
Sponsors
Department of Thoracic Surgery, Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient with age = 18 years old, gender is not limited. 2. Pathological diagnosis of NSCLC confirmed at surgery, any histology. 3. Union for International Cancer Control (UICC) v8 Stage II NSCLC after complete surgical resection with resection margins proved microscopically free of disease (R0) 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 5. Meet the conditions for receiving platinum containing dual drug chemotherapy; 6. Available tumor sample obtained for programmed cell death ligand-1 (PD-L1) expression assessment 7. Adequate organ function 8. Female participants of childbearing potential must be willing to use proper methods of birth control and should not breastfeed starting with the first infusion of study treatment through 3 months after the last infusion of study treatment. Female participants of childbearing potential have a negative urine or serum pregnancy test at screening. 9. Male participants must agree to use an adequate method of contraception starting with the first infusion of study treatment through 3 months after the last infusion of study treatment 10. The subjects themselves participated voluntarily and signed the informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Histopathology with large cell endocrine carcinoma(LCNEC). 2. Harboring EGFR sensitizing mutation or ALK gene translocation, and non-squamous cell NSCLC patients with unknown EGFR status. 3. Tumor disease and history: History of other malignant tumors, except for non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and no evidence of any disease for >5 years after the last treatment. 4. Previous antitumor therapy: No prior or planned neo-adjuvant radiotherapy and/or neo-adjuvant chemotherapy for the current malignancy is allowed; Prior treatment with anti-programmed cell death (anti-PD)-1, anti-PD ligand-1/2, anti-CD137, or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) modulators or any other immune-modulating agents; At the start of the study treatment, there are residual toxicities of the previous treatment that are greater than CTCAE 1 and have not been alleviated, except for alopecia and grade 2 neurotoxicity caused by previous chemotherapy. 5. Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, active bleeding, active infection including hepatitis B, C, HIV, etc., which the investigator considers unsuitable to participate in the study or affect the trial program compliance. History of ILD, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease. Insufficient bone marrow reserve or organ function. 6. History of hypersensitivity reactions to any active or inactive ingredient of tislelizumab or to drugs that are chemically similar to tislelizumab or in the same class of tislelizumab. 7. Patients who, in the judgment of the investigator, may not comply with the procedures and requirements of the study. 8. Patients who, in the investigator's judgment, have any condition that compromises patient safety or interferes with the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-years OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year DFS rate;2-year DFS rate;2-year OS rate;3-year OS rate; | — |
Countries
China
Contacts
Public ContactLi Wei
Henan Provincial People's Hospital
Outcome results
None listed