Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III)
Conditions
Interventions
Treatment Arm:Tislelizumab + Chidamide
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients must have histologically- or cytologically-documented NSCLC; 2.Patients with locally advanced, unrespectable, refuse, unacceptable surgery (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology); 3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy, the final chemotherapy cycle must end prior to, or concurrently with, the final dose of radiation. Consolidation chemotherapy after radiation is not permitted but administration of chemotherapy prior to concurrent chemoradiation is acceptable.Patients must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy), mean lung dose must be = 3 Month at Day 1; 8.Absolute neutrophil count(ANC) >1.5 x 10^9/L (1500 per mm3),Platelets >80 x 10^9/L (100,000 per mm3),Haemoglobin >= 8.0 g/dL 9.INR/PT <= 1.5 x ULN; 10.aPTT <= 1.5 x ULN; 11.Serum bilirubin <= 1.5 x upper limit of normal (ULN). Patients with confirmed Gilberts syndrome 3 x upper limit of normal (ULN); 12.AST and ALT <= 2.5 x ULN; 13.Provision of signed, written and dated informed consent prior to any study specific procedures; 14.patients must be willing to use effective contraception during the study period and within 120 days of the last administration of Tislelizumab.
Exclusion criteria
Exclusion criteria: 1. Patients with EGFR-sensitive mutations and ALK rearrangement in NSCLC; 2. Prior exposure to any HADCi; 3. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody, anti-CTLA4 antibody, and other CheckPoint Inhibitor; 4. Patient with a known history of allergy to the drug components of this study; 5. The patient has a history of other malignant tumors within 5 years; 6. Patients with any grade pneumonitis requiring oral or intravenous steroids; 7. The patient received sequential radiotherapy; 8. Patients progressed following definitive, platinum-based, concurrent chemoradiation therapy; 9. Any unresolved toxicity CTCAE > Grade 2 from the prior chemoradiation therapy. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study drug may be included (eg, hearing loss) after consultation with PI; 10. Grade 2 from pneumonitis from prior chemoradiation therapy; 11. Live attenuated vaccines within 30 days of dosing. Inactivated viruses such as those in the influenza vaccine are permitted; 12. There are active infection (4 weeks before screening of active bacteria, viruses, fungi, mycobacteria, parasitic infections, or other infections (not including nail bed fungus infection), or need intravenous antibiotics, or targeted antiviral treatment, or any major in hospital infection, or persistent fever screening before 14 days; 13. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 14. Patients with active autoimmune diseases requiring systemic treatment were assessed by the investigators as having an impact on the study protocol. 15. Patients with long-term or high dose of steroids (>= 10mg/d prednisone or equivalent dose of other steroids) or other immunosuppressive therapy were evaluated by the investigator s having an impact on the study protocol. 16. Uncontroled cardiovascular diseases; A clinically significant history of prolonged QT interval, or screening period of QTc interval > 450 ms; 17.Abnormal liver function Liver (Serum bilirubin > 1.5 x ULN,AST or ALT >2.5 x ULN), renal dysfunction (serum creatinine > 1.5 ULN); 18. Concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) that, according to the investigator's judgment, pose a serious risk to the patient's safety or affect the completion of the study; 19. A clear history of neurological or psychiatric disorders, including epilepsy or dementia; 20. The researcher judged that the patient was not fit to participate in the study. 21. The patients also participated in other clinical studies. 22. Mixed with SCLC.,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6m PFS Rate;12m PFS Rate; | — |
Countries
China
Contacts
Public ContactYi Hu
Chinese PLA General Hospital
Outcome results
None listed