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

NCT04371796 | Unknown Phase 2

• 1 other identifier: EK2019001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

NSCLC; neoadjuvant; Sintilimab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Disease Control Rate (DCR)

  up to 2 years

• Overall response rate (ORR)

  up to 2 years

• Disease-free survival (DFS)

  up to 2 years

• Incidence of irAEs

  up to 2 years

• Incidence of SAEs

  up to 2 years

Study Arms (1)

Sintilimab injection

EXPERIMENTAL

* 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

Interventions

Sintilimab injection DRUG

Sintilimab injection 200mg, 2cycles of treatment before surgery

Also known as: IBI308, Xindili Dankang

Sintilimab injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead
• Innovent Biologics, Inc.: collaborator

MeSH Terms

Conditions

Lung Diseases; Neoplasms; Respiratory Tract Diseases; Thoracic Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms

Study Officials

• Juan Li, MD

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Li, MD

CONTACT

+8613880276636; dr.lijuan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: May 10, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share