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

NCT ID: NCT04371796

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-10
• Study Completion Date: 2021-12-30

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sintilimab injection

• 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.

Group Type: EXPERIMENTAL

Sintilimab injection

Intervention Type: DRUG

Sintilimab injection 200mg, 2cycles of treatment before surgery

Interventions

Sintilimab injection

Sintilimab injection 200mg, 2cycles of treatment before surgery

Intervention Type: DRUG

Other Intervention Names

IBI308; Xindili Dankang

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics, Inc.

OTHER

Sponsor Role: collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Juan LI, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Li, MD

Role: PRINCIPAL_INVESTIGATOR

Sichuan Cancer Hospital and Research Institute

Central Contacts

Juan Li, MD

Role: CONTACT

dr.lijuan@gmail.com

+8613880276636

Other Identifiers

EK2019001

Identifier Type: -

Identifier Source: org_study_id