Status:
UNKNOWN
Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
Lead Sponsor:
Sichuan Cancer Hospital and Research Institute
Collaborating Sponsors:
Innovent Biologics, Inc.
Conditions:
Lung Diseases
Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Detailed Description
Sintilimab injection (IBI308) as neoadjuvant therapy in patients with resectable NSCLC
Eligibility Criteria
Inclusion
- Age: 18 years old to 75 years old, male or female;
- Histologically or cytologically confirmed NSCLC (stage II-IIIA, American Joint Committee on Cancer, eighth edition) that was surgically resectable;
- Being treatment-naive and the diameter of primary tumor was greater than or equal to 1 cm;
- ECOG performance status score: 0-1;
- 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.
- Estimated survival time≥3 months;
- PD-L1 expression level ≥ 1%；
- Patients were voluntarily enrolled in the study and signed an informed consent form (ICF) with good adherence and follow-up.
Exclusion
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose\>10 mg / day of prednisone or other therapeutic hormones);
- History of interstitial lung disease;
- Severe allergic reactions to other monoclonal antibodies;
- Previous allogeneic organ transplantation or hemopoietic stem cell transplantation;
- Have clinical symptoms or disease that are not well controlled ;
- Grade III to grade IV congestive heart failure;
- Uncontrolled hypertension;
- Artery thrombosis, embolism, or ischemia within 6 months before study treatment;
- Coagulation disorders;
- Active and uncontrolled infection;
- The patient has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1;
- Any other known malignant tumor;
Key Trial Info
Start Date :
May 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04371796
Start Date
May 10 2020
End Date
December 30 2021
Last Update
May 1 2020
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