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

NCT03428022 | Unknown Phase 3 DMC

• 1 other identifier: AFLC
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC; Apatinib; EGFR-TKI

Keywords

Apatinib; EGFR-TKI resistance; slowly progress

Outcome Measures

Primary Outcomes (1)

• PFS

  the disease progression free survival of patients

  3 months

Secondary Outcomes (2)

• OS

  8 months

• ORR

  6 months

Study Arms (1)

Apatinib combined with EGFR-TKI

EXPERIMENTAL

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

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

Interventions

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

Apatinib combined with EGFR-TKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

Study Officials

• CAO HUA, MD

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CAO HUA, MD

CONTACT

0086-755-22942406; caohua1206@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 9, 2018
• Study Start: December 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

CN (1)