Clinical Trials /

APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC

NCT03164694

Description:

The purpose of this study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC
  • Official Title: A Multicenter Phase II Trial of Pemetrexed Plus Carboplatin With or Without Apatinib in Patients With Advanced Non-small Cell Lung Cancer Without EGFR Mutation, ALK Gene Rearrangement, and ROS1 Gene Rearrangement

Clinical Trial IDs

  • ORG STUDY ID: GASTO1006
  • NCT ID: NCT03164694

Conditions

  • Lung Cancer

Interventions

DrugSynonymsArms
ApatinibApatinib
PemetrexedApatinib
CarboplatinApatinib

Purpose

The purpose of this study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.

Detailed Description

      Platinum-based chemotherapy is the recommended therapeutic approach for patients with
      advanced non-small cell lung cancer (NSCLC) without EGFR mutation, ALK gene rearrangement,
      and ROS1 gene rearrangement. However, the prognosis of advanced NSCLC remains poor. Apatinib
      is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2.
      Apatinib has been proved to be effective and safe in heavily pretreated patients with gastric
      cancer. This study is to studying the addition of apatinib with chemotherapy to investigate
      the efficacy and safety of apatinib in combination with chemotherapy in patients with
      advanced NSCLC.
    

Trial Arms

NameTypeDescriptionInterventions
ApatinibExperimentalPatients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5) plus apatinib. Apatinib was given 850 mg per day orally at day one of chemotherapy.
  • Apatinib
  • Pemetrexed
  • Carboplatin
ControlActive ComparatorPatients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5).
  • Pemetrexed
  • Carboplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Target population is advanced NSCLC (IIIB-IV) without EGFR mutation, ALK gene
             rearrangement, and ROS1 gene rearrangement.

          -  Written informed consent provided.

          -  Male and female patients aged ≥18 years, < 75 years.

          -  Able to comply with the required protocol and follow-up procedures, and able to
             receive oral medications.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

          -  Life expectancy ≥12 weeks.

          -  Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and
             Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or
             exceed this level).

          -  Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN),
             Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in
             subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.

          -  Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.

          -  Female subjects should not be pregnant or breast-feeding.

        Exclusion Criteria:

          -  Known severe hypersensitivity to apatinib or any of the excipients of this product.

          -  Inability to comply with protocol or study procedures.

          -  A serious concomitant systemic disorder that, in the opinion of the investigator,
             would compromise the patient's ability to complete the study.

          -  A serious cardiac condition, such as myocardial infarction within 6 months, angina, or
             heart disease.

          -  Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g.
             monoclonal antibody therapy).

          -  Patients with prior radiotherapy

          -  History of another malignancy in the last 5 years with the exception of the following:
             other malignancies cured by surgery alone and having a continuous disease-free
             interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in
             situ carcinoma of the uterine cervix are permitted.

          -  Any unstable systemic disease (including active infection, uncontrolled hypertension,
             unstable angina, congestive heart failure, myocardial infarction within the previous
             year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic
             disease).

          -  Eye inflammation or eye infection not fully treated or conditions predisposing the
             subject to this.

          -  Evidence of any other disease, neurological or metabolic dysfunction, physical
             examination or laboratory finding giving reasonable suspicion of a disease or
             condition that contraindicated the use of an investigational drug or puts the subject
             at high risk for treatment-related complications.

          -  Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival
Time Frame:1 year after the last patient is randomized
Safety Issue:
Description:Overall survival was assessed from randomization to death as a result of any cause.

Secondary Outcome Measures

Measure:Disease-free survival
Time Frame:1 year after the last patient is randomized
Safety Issue:
Description:Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
Measure:Number of Participants with Adverse Events
Time Frame:1 year
Safety Issue:
Description:To assess if the addition of apatinib to chemotherapy is safe.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sun Yat-sen University

Last Updated

May 22, 2017