Non-small cell lung cancer
Conditions
Interventions
Case series:Sintilimab Combined With Double Platinum Based Chemotherapy
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent provided; 2. Aged 18 years old to 75 years old, male or female; 3. Histological or cytological diagnosed of NSCLC; 4. At least 1 measurable lesion according to RECIST 1.1; 5. clinical stage IIIB according to the TNM classification (8th edition) that was surgically resectable primary tumor greater than or equal to 2 cm; 6. With expected feasibility of radical surgery therapy; 7. Surgeon evaluation for surgical resection with no contraindications to surgery; 8. ECOG performance status score 0-1; 9. Life expectancy is at least 6 mouths; 10. The function of important organs meets the study requirements.
Exclusion criteria
Exclusion criteria: 1. Have other malignant tumors in the last 5 years; 2. Currently participating in other interventional clinical research treatment or has received another investigational drug or used an investigational device within 4 weeks prior to the first dose; 3. Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways; 4. Have received systemic therapy with a proprietary or immunomodulatory drug with an antitumor indication (including thymidine, interferon, and interleukin, except for topical use to control pleural effusion) within 2 weeks prior to the first dose; 5. Active autoimmune disease requiring systemic therapy that occurredwithin 2 years prior to the first dose (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants). [ Replacement therapy is not considered systemic therapy (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency)]; 6. Receiving systemic glucocorticosteroid therapy (excluding topical glucocorticosteroids by nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy within 7 days prior to the study's first administration; 7. History of allogeneic tissue/solid organ transplant[Except corneal transplantation]; 8. Allergy to the test drug; 9. Have not recovered sufficiently from toxicity and/or complications from any of the interventions prior to initiating treatment (i.e., <=grade 1 or at baseline, not including weakness or hair loss); 10. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); 11. Active untreated HBV (defined as HBsAg positivity and detection of HBV-DNA copy number greater than the upper limit of normal in the testing department at the study center); active HCV-infected subjects (HCV antibody positivity and HCV-RNA levels above the lower limit of detection); 12. Has received a live vaccine within 30 days prior to the first dose of trial treatment. [Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed.]; 13. Women in pregnancy or lactation; 14. There are any uncontrolled systemic diseases; 15. Other situations in which investigators thought the patients not suit to be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathologic Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;R0 resection rate;Disease-free survival;Overall survival;Drug-Related Adverse Events;Surgical Complications;No Surgical Delay Rate; | — |
Countries
China
Contacts
Public ContactKai Ma
Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed