Clinical Trials /

The Efficacy and Safety of Apatinib Combined With Etoposide in Heavily Pretreated Advanced Non-small Cell Lung Cancer

NCT02733107

Description:

The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung cancer which is recommended by NCCN guideline. The investigators wondered whether these two drugs have synergistic effects when treating advanced non-small cell lung cancer patients who failed to previous at least 2nd line treatments. Thus, the aim of this trial is to investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated advanced non-small cell lung cancer.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: The Efficacy and Safety of Apatinib Combined With Etoposide in Heavily Pretreated Advanced Non-small Cell Lung Cancer
  • Official Title: The Efficacy and Safety of Apatinib Combined With Etoposide in Advanced Non-small Cell Lung Cancer Patients Failed to Previous at Least 2rd Line Treatments

Clinical Trial IDs

  • ORG STUDY ID: ACEL
  • NCT ID: NCT02733107

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
ApatinibApatinib+Etoposide
EtoposideVP-16Apatinib+Etoposide

Purpose

The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung cancer which is recommended by NCCN guideline. The investigators wondered whether these two drugs have synergistic effects when treating advanced non-small cell lung cancer patients who failed to previous at least 2nd line treatments. Thus, the aim of this trial is to investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated advanced non-small cell lung cancer.

Trial Arms

NameTypeDescriptionInterventions
Apatinib+EtoposideOtherApatinib combined with Etoposide
  • Apatinib
  • Etoposide

Eligibility Criteria

        Inclusion Criteria:

          -  Obtain of informed consent.

          -  Histologically or cytologically confirmed non-small cell lung cancer.

          -  World Health Organization (WHO) performance status (PS) of 0 to 2.

          -  Measurable lesions as defined by RECIST criteria.

          -  Second-line or more treatments.

          -  Wild type of epidermal-growth-factor receptor (EGFR).

          -  Life expectancy ≥12 weeks.

          -  Organ functions normal, as defined below, within two weeks of randomization:

             • Hb≥90g/L Absolute neutrophils count(ANC)≥1.5×109/L Platelets≥80×109/L Serum
             bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase
             (ALT)≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥45ml/min or
             Cr≤1.25×ULN.

          -  Females of child-bearing potential must have negative serum pregnancy test.

          -  Sexually active males and females (of childbearing potential) willing to practice
             contraception during the study.

        Exclusion Criteria:

          -  Small cell lung cancer.

          -  Newly diagnosed Central Nervous System (CNS) metastases that have not yet been
             definitively treated with surgery and/or radiation.

          -  Uncontrolled hypertension.

          -  Myocardial ischemia or infarction more than stage II, cardiac insufficiency.

          -  Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or
             receiving coagulation therapy.

          -  Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic
             bacillary diarrhea and intestinal obstruction).

          -  Hemoptysis, more than 2.5ml daily.

          -  Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous
             thrombosis.

          -  Unhealed bone fracture or wound for long time.

          -  Received big surgery, had bone fracture or ulcer in 4 weeks.

          -  Urine protein≥++, or urine protein in 24 hours≥1.0g.

          -  Pregnant or lactating woman.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival
Time Frame:evaluated in 24 months since the treatment began
Safety Issue:
Description:the first day of treatment to the date that disease progression is reported

Secondary Outcome Measures

Measure:Objective Response Rate
Time Frame:tumor assessment every 6-8 weeks since the treatment began,up to 24 months
Safety Issue:
Description:the ratio between the number of responders and number of patients assessable for tumor response
Measure:Overall survival
Time Frame:the first day of treatment to death or last survival confirm date,up to 24 months
Safety Issue:
Description:
Measure:Side effects
Time Frame:evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Third Military Medical University

Trial Keywords

  • Non-small Cell Lung Cancer
  • Apatinib
  • Etoposide

Last Updated