Apatinib Combined With SHR-1210 Injection in the Treatment of Patients With Removable IB-IIIA NSCLC

Neoplasms Clinical Trial

Official title:

One-arm Exploratory Study on the Efficacy and Safety of Apatinib Combined With SHR-1210 Injection (PD-1 Antibody) in the Treatment of Removable IB-IIIA Non-small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04133337
• Other study ID #: HR-SHR-NSCLC201906
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2019
• Est. completion date: June 2021

Study information

• Verified date: October 2019
• 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 SHR-1210 in combination with the anti-vascular survival target drug apatinib in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with the period IB-IIIA NSCLC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2021
• Est. primary completion date: June 1, 2020
• 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. Initial treatment of patients with IB-IIIA non-small cell lung cancer who are expected to be surgically resected;

• 3. Histopathologically confirmed non-small cell lung cancer with measurable tumor lesions (spiral CT scan=10mm, meeting RECIST 1.1 criteria);

• 4. ECOG PS: 0-1 points

• 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. Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours prior to the first study drug administration and are shown to be negative ,and willing to be 3 months after the last dose of SHR-1210 injection during the trial period. The effective method was used for contraception (from the control group to 180 days after the last administration). For male subjects whose partners are women of childbearing age, effective methods should be used during the test period and within 3 months after the last administration of SHR-1210 injection (control group to 180 days after the last administration);

• 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.Interstitial pneumonia ;

• 4.Severe allergic reactions to other monoclonal antibodies ;

• 5.Suffering from high blood pressure and not being well controlled by antihypertensive medication (systolic blood pressure=140 mmHg or diastolic blood pressure=90 mmHg) ;

• 6.Have clinical symptoms or disease that are not well controlled ;

• 7.Abnormal coagulation function (INR>2.0, PT>16s), bleeding tendency or receiving thrombolysis or anticoagulant therapy, allowing prophylactic use of low-dose aspirin, low molecular weight heparin;

• 8.There was significant coughing blood in the first 2 months before enrollment, or daily hemoptysis amounted to 2.5ml or more;

• 9.Significant clinically significant bleeding symptoms or a clear tendency to hemorrhage during the first 3 months of randomization;

• 10.Urinary routine suggests urinary protein= ++ and confirmed 24-hour urine protein> 1.0 g ;

• 11.The patient has active infection, unexplained fever within 3 days before administration, =38.5 °C, or baseline white blood cell count>15×109/L;

• 12.The patient has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1;

• 13.Other patients considered by the treating physician not suitable for inclusion .

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Diseases
• Lung Neoplasms
• Neoplasms
• Non-small-cell Lung Cancer
• Respiratory Tract Diseases
• Thoracic Neoplasms

Intervention

Drug:
• Apatinib
Apatinib Mesylate Tablets
• SHR-1210
Camrelizumab for Injection

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of irAEs	Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)	up to 2 years
Other	Incidence of SAEs	Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)	up to 2 years
Primary	Major pathologic response rate(MPR)(<10% viable tumor cells)	To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving Apatinib Combined With SHR-1210 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