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

Phase 3

• Conditions: Apatinib; EGFR-TKI; NSCLC
• Interventions: Drug: Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）

• Registration Number: NCT03428022
• Lead Sponsor: Shenzhen People's Hospital

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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-02-04
• Study First Posted: 2018-02-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib combined with EGFR-TKI	Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）	Apatinib（Tablet（Tab. ）500millgram（mg）/day（d）） combined with EGFR-TKI（as previously）

Primary Outcome Measures

Name	Time	Method
PFS	3 months	the disease progression free survival of patients

Secondary Outcome Measures

Name	Time	Method
ORR	6 months	objective response rates
OS	8 months	overall survival

Trial Locations

Locations (1)

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China