Clinical trial NCT04371796: Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
Official title: Exploratory Efficacy and Safety Study of PD-1 Inhibitor Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Diseases
Neoplasms
Respiratory Tract Diseases
Thoracic Neoplasms
Non-small-cell Lung Cancer
Keywords: NSCLC
neoadjuvant
Sintilimab
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Innovent Biologics, Inc.
First posted: 2020-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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;

Primary outcomes:
measure: Major pathologic response rate(MPR)(<10% viable tumor cells)
timeFrame: At time of surgery
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: up to 2 years
measure: Overall response rate (ORR)
timeFrame: up to 2 years
measure: Disease-free survival (DFS)
timeFrame: up to 2 years
measure: Incidence of irAEs
timeFrame: up to 2 years
measure: Incidence of SAEs
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Juan Li, MD
role: PRINCIPAL_INVESTIGATOR
References: