Non-small-cell lung cancer
Conditions
Interventions
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with stage III (AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery; 2. Intolerable of concurrent chemoradiotherapy; 3. No progression after radiotherapy or sequential chemoradiotherapy; 4. Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine in combination with platinum; Radiotherapy: starting within 3 months after chemotherapy using IMRT or VMAT technique. The target volume includes the primary tumor and regional lymph nodes, and the prescription dose 95% PTV ranges from 50 Gy to 66 Gy; 5. ECOG PS0-2; 6. PD-L1 >= 1%; 7. Aged >= 18 years, and life expectancy >3 months; 8. Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose): (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90 g/L; (2) International normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN; (3) Activated partial thromboplastin time (aPTT) <= 1.5 x ULN; (4) Total serum bilirubin <= 1.5 x ULN (patients with Gilbert's syndrome may be enrolled if total bilirubin is < 3 x ULN); (5) Glutamic aminotransferase (AST) and glutamic alanine aminotransferase (ALT) <= 2.5 x ULN, or if the patient has liver metastases, this criterion is AST and ALT <= 5 x ULN; 9. Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule.
Exclusion criteria
Exclusion criteria: 1. Patients with EGFR-sensitive mutations and ALK rearrangements; 2. Any prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including Ipilimumab or any other antibody targeting the T-cell co-stimulation or checkpoint pathway); 3. History of allergy to components of Tislelizumab; 4. Any active malignancy within 2 years prior to enrollment, except for the specific cancers examined in this study and any locally recurrent cancers that have been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ); 5. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids; 6. Unresolved >= grade 2 toxicities from radiotherapy and sequential chemoradiotherapy, (excluding those that the investigator determines do not affect study treatment, such as alopecia); 7. Grade 2 or severe Pneumonia from radiotherapy or sequential chemoradiotherapy; 8. Administration of a live vaccine within 30 days prior to treatment start (seasonal influenza vaccine without live vaccine is allowed); 9. Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic antibacterial, antifungal or antiviral therapy = 10 mg/d prednisone or equivalent doses of other steroids) or other immunosuppressive medications; 13. History of uncontrolled cardiovascular disease; or clinically significant QT interval prolongation, or QTc interval > 480 ms during screening period; 14. Abnormal renal function (serum creatinine > 1.5 times of the upper limit of normal value); 15. History of serious concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.); 16. History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia; 17. Unsuitable for participation in this study assessed by investigators; 18. Patients who were already enrolled in other clinical studies; 19. Mixed lung cancer with small cell components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Safety profiles; | — |
Countries
China
Contacts
Public ContactRong Yu
Peking University Cancer Hospital
Outcome results
None listed