NSCLC
Conditions
Interventions
experimental group:Sintilimab+Platinum containing chemotherapy
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent provided; 2. Male or female aged 18-70 years; 3. Participants must have a measurable disease (RECIST v1.1); 4. Target population is resectable stage II-IIIa non-small cell lung cancer; 5. Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. No prior treatment for this disease; 8. Adequate hematological function: Absolute neutrophil (ANC)>=1.5x10^9/L, platelets (PLT)100x10^9/L, Hemoglobin (HGB)>=90g/L, (No transfusion or erythropoietin dependence=60 ml/min (Cockcroft-Gault). Urine protein less than 2+ by urinalysis or 24-hour urinary protein quantity < 1g; 11. Adequate coagulation function, defined as: international normalized ratio (INR) or prothrombin time (PT) <=1.5 x ULN. For patients receiving anticoagulant therapy can be enrolled if PT is within the range defined by anticoagulant therapy; 12. For women of child-bearing age, a negative urine or serum pregnancy test should be conducted 3 days prior to the first study drug administration; 13. All subjects of childbearing potential must agree to use efficient contraceptive methods that result in a failure rate of < 1% per year during the study treatment period and for at least 180 days after discontinuation from study treatment.
Exclusion criteria
Exclusion criteria: 1. Previous immune therapy including: anti PD-1, anti PD-L1, anti PD-L2 or treatment targeting other co-stimulatory or co-inhibitory T-cell receptors [e.g. cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, and CD137]; 2. Systemic therapy with Chinese patent medicine or drugs of immunoregulation effect (including thymosin, interferon, interleukin, unless local delivery for controlling pleural effusion) within 2 weeks prior to the first dose of study treatment, or major surgery within 3 weeks prior to the first dose of study treatment; 3. Clinical evidence of active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 4. Previous organ or blood system transplantation; 5. Clinically uncontrollable third interstitial effusion, such as pleural and ascites; 6. Known severe hypersensitivity to Sintilimab or any of the Drugs of this protocol; 7. A history of active autoimmune disease requiring systemic treatment (e.g. using drugs for disease remission, corticosteroids or immunosuppressor) within 2 years prior to the first dose of study treatment. Substitution therapy (e.g. thyroxine, insulin or physiological corticosteroids for treating adrenal or pituitary dysfunction) is not considered as a systemic treatment; 8. Diagnosis as immunodeficiency, or being treated with systemic glucocorticoid or other kinds of immunosuppressor within 7 days prior to the first dose of study treatment. A physiological dose of glucocorticoid ( the lower detection limit); 17. Live vaccine was given within 1 month before the first dose Note: inactivated virus vaccine for seasonal;influenza is allowed within 30 days prior to the first dose, but live attenuated influenza vaccine for intranasal administration is not allowed; 18. History or evidence of disease, treatment or laboratory abnormalities that would interfere the study outcome, prevent patients from participating entirely, or ineligible to enroll
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;MPR;PCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;ORR; | — |
Countries
China
Contacts
Public ContactKunyu Yang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed