Back to resultsSintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
Primary Purpose
Lung Diseases, Neoplasms, Respiratory Tract Diseases
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sintilimab injection
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases focused on measuring NSCLC, neoadjuvant, Sintilimab
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sintilimab injection
Arm Description
Drugs: Eligible patients received two doses of intravenous sintilimab (200 mg) every 3 weeks (Q3W). Each infusion time is 30-60min. Surgery: The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 6-8 weeks after the first dose.
Outcomes
Primary Outcome Measures
Major pathologic response rate(MPR)(<10% viable tumor cells)
To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving Sintilimab Injection
Secondary Outcome Measures
Disease Control Rate (DCR)
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)
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)
Defined as the time from date of surgery until recurrence of tumor or death from any cause
Incidence of irAEs
Immune-related AE per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Incidence of SAEs
Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Full Information
NCT ID
NCT04371796
First Posted
April 29, 2020
Last Updated
April 29, 2020
Sponsor
Sichuan Cancer Hospital and Research Institute
Collaborators
Innovent Biologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04371796
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute
Collaborators
Innovent Biologics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Neoplasms, Respiratory Tract Diseases, Thoracic Neoplasms, Non-small-cell Lung Cancer
Keywords
NSCLC, neoadjuvant, Sintilimab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sintilimab injection
Arm Type
Experimental
Arm Description
Drugs: Eligible patients received two doses of intravenous sintilimab (200 mg) every 3 weeks (Q3W). Each infusion time is 30-60min.
Surgery: The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 6-8 weeks after the first dose.
Intervention Type
Drug
Intervention Name(s)
Sintilimab injection
Other Intervention Name(s)
IBI308, Xindili Dankang
Intervention Description
Sintilimab injection 200mg, 2cycles of treatment before surgery
Primary Outcome Measure Information:
Title
Major pathologic response rate(MPR)(<10% viable tumor cells)
Description
To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving Sintilimab Injection
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
up to 2 years
Title
Overall response rate (ORR)
Description
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
Time Frame
up to 2 years
Title
Disease-free survival (DFS)
Description
Defined as the time from date of surgery until recurrence of tumor or death from any cause
Time Frame
up to 2 years
Title
Incidence of irAEs
Description
Immune-related AE per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Time Frame
up to 2 years
Title
Incidence of SAEs
Description
Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Li, MD
Phone
+8613880276636
Email
dr.lijuan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Li, MD
Organizational Affiliation
Sichuan Cancer Hospital and Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
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