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

NCT ID: NCT03428022

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-12-31

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.

Conditions

NSCLC; Apatinib; EGFR-TKI

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib combined with EGFR-TKI

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

Group Type: EXPERIMENTAL

Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cao，Hua

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CAO HUA, MD

Role: PRINCIPAL_INVESTIGATOR

Shenzhen People's Hospital

Locations

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

CAO HUA, MD

Role: CONTACT

caohua1206@hotmail.com

0086-755-22942406

Facility Contacts

CAO HUA, MD

Role: primary

caohua1206@hotmail.com

0086-755-22942406

Other Identifiers

AFLC

Identifier Type: -

Identifier Source: org_study_id