Apatinib Combined With EGFR-TKI for Advanced Slow-progressed EGFR-TKI Resistant NSCLC

NSCLC Clinical Trial

— AFLC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03428022
• Other study ID #: AFLC
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2019
• Source: Shenzhen People's Hospital
• Contact: CAO HUA, MD
• Phone: 0086-755-22942406
• Email: caohua1206[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Apatinib
• EGFR-TKI
• NSCLC

Intervention

Drug:
• Apatinib(Tab. 500mg/d) combined with EGFR-TKI(as previously)
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	the disease progression free survival of patients	3 months
Secondary	OS	overall survival	8 months
Secondary	ORR	objective response rates	6 months