non-small cell lung cancer
Conditions
Interventions
single-arm:IBI308 200mg iv, Q3W, 2cycles
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-small cell lung cancer diagnosed by cytology or histology; 2. Agree to have histologic tumor sample collected; 3. Untreated, resectable non-small cell lung cancer with a diameter larger than 2cm; 4. Agree to have radical surgery; 5. No surgery contraindications decided by thoracic surgeons; 6. At least one measurable focus(RECIST v1.1); 7. Male or female>=18 years old, and=1.5*10^9/L, PLT>=100*10^9/L, HGB>=9g/dL; 10. Liver function: TBIL=2.8g/dL; 11. Renal function: Cr=40mL/min; 12. Written informed consent form being signed.
Exclusion criteria
Exclusion criteria: 1. EGFR sensitive by histologic tumor sample biopsy; 2. Previous anti-cancer therapy, including radiation therapy, chemotherapy, immunotherapy and traditional Chinese medicine therapy; 3. Use of immuno-inhibitory drugs within 4 weeks of initial IBI308 treatment, not including nasal, inhaled or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids; 4. Known or suspicious active autoimmune disease(congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc.; 5. Known allogeneic organ transplantation (excluding cornea) or allogeneic hematopoietic stem cell transplantation; 6. Allergic to monoclonal antibodies; 7. Suffering from interstitial lung disease; 8. Suffering from other serious uncontrolled diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| drug-related adverse event;surgery complications;no-delay surgery rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;major pathologic response;disease free survival;recurrence rate of 1 and 2 years;overall survival; | — |
Countries
China
Contacts
Public ContactJie He
Outcome results
None listed