Clinical trial NCT04133337: Apatinib Combined With SHR-1210 Injection in the Treatment of Patients With Removable IB-IIIA NSCLC
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lung Diseases
Neoplasms
Respiratory Tract Diseases
Thoracic Neoplasms
Non-small-cell Lung Cancer
Keywords: Apatinib
SHR-1210
NSCLC
neoadjuvant
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2019-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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 .

Primary outcomes:
measure: Major pathologic response rate(MPR)(<10% viable tumor cells)
timeFrame: At time of surgery
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: up to 2 years
measure: Overall response rate (ORR)
timeFrame: up to 2 years
measure: Disease-free survival (DFS)
timeFrame: up to 2 years
Other outcomes:
measure: Incidence of irAEs
timeFrame: up to 2 years
measure: Incidence of SAEs
timeFrame: up to 2 years
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Juan Li, MD
role: PRINCIPAL_INVESTIGATOR
References: