Lung Diseases, Neoplasms, Respiratory Tract Diseases, Thoracic Neoplasms, Non-small-cell Lung Cancer
Conditions
Keywords
NSCLC, neoadjuvant, Sintilimab
Brief summary
The aim of this study was to investigate the safety and efficacy of Sintilimab (IBI308) in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with stage II-IIIA NSCLC
Detailed description
Sintilimab injection (IBI308) as neoadjuvant therapy in patients with resectable NSCLC
Interventions
Sintilimab injection 200mg, 2cycles of treatment before surgery
Sponsors
Innovent Biologics, Inc.
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 years old to 75 years old, male or female; 2. Histologically or cytologically confirmed NSCLC (stage II-IIIA, American Joint Committee on Cancer, eighth edition) that was surgically resectable; 3. Being treatment-naive and the diameter of primary tumor was greater than or equal to 1 cm; 4. ECOG performance status score: 0-1; 5. The function of important organs meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of study): Absolute neutrophil count (ANC)≥1.5×10 E+9/L; platelets≥100×10E+9/L / L; hemoglobin ≥9g/dL; serum albumin(ALB)≥2.8g/dL; a total bilirubin (TBil) of≤1.5 ULN, ALT and AST≤2.5 ULN, in case of liver metastasis, ALT and AST≤5 ULN; creatinine clearance rate≥ 50mL/min(Cockcroft-Gault);thyroid function is normal. 6. Estimated survival time≥3 months; 7. PD-L1 expression level ≥ 1%； 8. Patients were voluntarily enrolled in the study and signed an informed consent form (ICF) with good adherence and follow-up.
Exclusion criteria
1. The patient has any active autoimmune disease or a history of autoimmune disease; 2. The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose\>10 mg / day of prednisone or other therapeutic hormones); 3. History of interstitial lung disease; 4. Severe allergic reactions to other monoclonal antibodies; 5. Previous allogeneic organ transplantation or hemopoietic stem cell transplantation; 6. Have clinical symptoms or disease that are not well controlled ; 7. Grade III to grade IV congestive heart failure; 8. Uncontrolled hypertension; 9. Artery thrombosis, embolism, or ischemia within 6 months before study treatment; 10. Coagulation disorders; 11. Active and uncontrolled infection; 12. The patient has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1; 13. Any other known malignant tumor;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major pathologic response rate(MPR)(<10% viable tumor cells) | At time of surgery | To assess the major pathologic response rate (\<10% viable tumor cells) in patients receiving Sintilimab Injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | up to 2 years | the proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator. |
| Overall response rate (ORR) | up to 2 years | the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator |
| Disease-free survival (DFS) | up to 2 years | Defined as the time from date of surgery until recurrence of tumor or death from any cause |
| Incidence of irAEs | up to 2 years | Immune-related AE per Common Terminology Criteria for Adverse Events (CTCAE V5.0) |
| Incidence of SAEs | up to 2 years | Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0) |
Contacts
Primary ContactJuan Li, MD
Outcome results
None listed