Clinical trial NCT03428022: Apatinib Combined With EGFR-TKI for Advanced Slow-progressed EGFR-TKI Resistant NSCLC
Official title: Apatinib Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Used for the Advanced Slow-progressed Non Small Cell Lung Cancer Patients With EGFR-TKI Resistance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: NSCLC
Apatinib
EGFR-TKI
Keywords: Apatinib
EGFR-TKI resistance
slowly progress
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with Apatinib and EGFR-TKI. The primary objective is the disease progression free survival of the patients.

Detailed description: Patients with advanced non-small cell lung cancer (NSCLC) who had treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI） and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI. The primary objective is the disease progression free survival of the patients. The secondary goals are overall survival, duration of response, objective response rates, disease control rates, quality of life scores and drug safety. Currently such patients are treated with EGFR-TKI continuously, but 3 months later, the disease will be progressed rapidly. This study will bring a new treatment that are more effective, less toxic and more convenient for NSCLC-patients with EGFR-TKI resistance.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed advanced (stage IV) non-squamous, non-small cell lung cancer with measurable lesions
* Electronics Coordinating Grop（ECOG）score：0-2
* Expected survival over 3months
* Hemoglobin(HB)≥90 gram(g)/liter(L)；absolute neutrophil count(ANC)≥1.5×109/L；platelet(PLT)≥80×109/L；total-bilirubin（T-BIL）\<1.5 upper limit of normal value（ULN）；alanine aminotransferase（ALT）and aspartate aminotransferase（AST）\<2.5 ULN；Cr≤1.25ULN

Exclusion Criteria:

* Brain metastases, meningococcal meningitis, patients with spinal cord compression with evidence of imaging (computed tomography（CT） / magnetic resonance imaging （MRI）, et cetera（etc.）);
* Uncontrolled hypertension (systolic blood pressure（BP）≥140 millimeter mercury column（mmHg） or diastolic BP ≥90 mmHg, despite optimal drug therapy);
* Hemorrhoid dysfunction (inernational standard ratio(INR)\> 1.5 or prothrombin time (PT)\> ULN + 4 seconds or activated partial thromboplastin(APTT)\> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
* Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like;
* Patients underwent major surgery or severe traumatic injury, fracture or ulcer in 4 weeks before study;
* Urine routine urine protein ≥ +++, or confirmed 24 hours urinary protein content ≥ 1.0 g;

Primary outcomes:
measure: PFS
timeFrame: 3 months
Secondary outcomes:
measure: OS
timeFrame: 8 months
measure: ORR
timeFrame: 6 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen People's Hospital
name: CAO HUA, MD
role: PRINCIPAL_INVESTIGATOR
References: