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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04133337
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Juan LI, MD, Sichuan Cancer Hospital and Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Diseases Neoplasms Respiratory Tract Diseases Thoracic Neoplasms Non-small-cell Lung Cancer Drug: Apatinib Drug: SHR-1210 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib Combined With SHR-1210 Injection
  • Drugs:Apatinib Apatinib mesylate tablets 250 mg qd po, discontinued one week before surgery.
  • Drugs: SHR-1210 SHR-1210 injection 200mg (5mL), ivgtt, q2w, 3 cycles, each time 20-60min completed infusion.
  • Surgery:

The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 7-8 weeks after the first dose.

Drug: Apatinib
Apatinib Mesylate Tablets
Other Names:
  • AiTan
  • H20140103

Drug: SHR-1210
Camrelizumab for Injection
Other Names:
  • Camrelizumab
  • Karuilizhu Dankang
  • S20190027




Primary Outcome Measures :
  1. Major pathologic response rate(MPR)(<10% viable tumor cells) [ Time Frame: At time of surgery ]
    To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving Apatinib Combined With SHR-1210 Injection.


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: 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.

  2. Overall response rate (ORR) [ Time Frame: 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

  3. Disease-free survival (DFS) [ Time Frame: up to 2 years ]
    Defined as the time from date of surgery until recurrence of tumor or death from any cause


Other Outcome Measures:
  1. Incidence of irAEs [ Time Frame: up to 2 years ]
    Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)

  2. Incidence of SAEs [ Time Frame: up to 2 years ]
    Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133337


Contacts
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Contact: Juan Li, MD +8613880276636 dr.lijuan@gmail.com

Locations
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China, Sichuan
Sichuan Cancer Hospital Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Juan Li, MD    +8613880276636    dr.lijuan@gmail.com   
Sponsors and Collaborators
Sichuan Cancer Hospital and Research Institute
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Juan Li, MD Sichuan Cancer Hospital and Research Institute

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Responsible Party: Juan LI, MD, MD, Sichuan Cancer Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT04133337     History of Changes
Other Study ID Numbers: HR-SHR-NSCLC201906
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan LI, MD, Sichuan Cancer Hospital and Research Institute:
Apatinib
SHR-1210
NSCLC
neoadjuvant
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Thoracic Neoplasms
Lung Diseases
Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Neoplasms by Site
Carcinoma, Bronchogenic
Bronchial Neoplasms
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action