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

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

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

Study Overview

• Status: Unknown
• Conditions: Neoplasms; Respiratory Tract Diseases; Lung Diseases; Thoracic Neoplasms; Non-small-cell Lung Cancer
• Intervention / Treatment: Drug: Sintilimab injection

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Sintilimab injection; Sintilimab injection 200mg, 2cycles of treatment before surgery; Other Names: IBI308; Xindili Dankang

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Incidence of SAEs	Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)	up to 2 years
Incidence of irAEs	Immune-related AE per Common Terminology Criteria for Adverse Events (CTCAE V5.0)	up to 2 years

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute
• Collaborators: Innovent Biologics, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 10, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: neoadjuvant; NSCLC; Sintilimab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Thoracic Neoplasms
• Other Study ID Numbers: EK2019001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No