Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC

Neoplasms Clinical Trial

Official title:

Exploratory Efficacy and Safety Study of PD-1 Inhibitor Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04371796
• Other study ID #: EK2019001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 10, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2020
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: Juan Li, MD
• Phone: +8613880276636
• Email: dr.lijuan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Sintilimab injection (IBI308) as neoadjuvant therapy in patients with resectable NSCLC

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Lung Diseases
• Neoplasms
• Non-small-cell Lung Cancer
• Respiratory Tract Diseases
• Thoracic Neoplasms

Intervention

Drug:
• Sintilimab injection
Sintilimab injection 200mg, 2cycles of treatment before surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute	Innovent Biologics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At time of surgery
Secondary	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.	up to 2 years
Secondary	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	up to 2 years
Secondary	Disease-free survival (DFS)	Defined as the time from date of surgery until recurrence of tumor or death from any cause	up to 2 years
Secondary	Incidence of irAEs	Immune-related AE per Common Terminology Criteria for Adverse Events (CTCAE V5.0)	up to 2 years
Secondary	Incidence of SAEs	Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)	up to 2 years