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

Phase 2

• Conditions: Respiratory Tract Diseases; Thoracic Neoplasms; Non-small-cell Lung Cancer; Lung Diseases; Neoplasms
• Interventions: Drug: Sintilimab injection

• Registration Number: NCT04371796
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

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

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Last Update Submitted: 2020-04-29
• Study First Posted: 2020-05-01
• Last Update Posted: 2020-05-01
• Study Start: 2020-05-10
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sintilimab injection	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.

Primary Outcome Measures

Name	Time	Method
Major pathologic response rate(MPR)(<10% viable tumor cells)	At time of surgery	To assess the major pathologic response rate (\<10% viable tumor cells) in patients receiving Sintilimab Injection

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	up to 2 years	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.
Disease-free survival (DFS)	up to 2 years	Defined as the time from date of surgery until recurrence of tumor or death from any cause
Incidence of SAEs	up to 2 years	Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Overall response rate (ORR)	up to 2 years	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
Incidence of irAEs	up to 2 years	Immune-related AE per Common Terminology Criteria for Adverse Events (CTCAE V5.0)