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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518020
      • Recruiting
      • ShenZhen People's Hospital
      • Contact: CAO HUA, MD; Phone Number: 0086-755-22942406; Email: caohua1206@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apatinib combined with EGFR-TKI; Apatinib（Tablet（Tab. ）500millgram（mg）/day（d）） combined with EGFR-TKI（as previously）	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	the disease progression free survival of patients	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	objective response rates	6 months
OS	overall survival	8 months

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Investigators: Principal Investigator: CAO HUA, MD, ShenZhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: February 4, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Apatinib; EGFR-TKI resistance; slowly progress
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: AFLC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No