Clinical Trials /

Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in NSCLC

NCT03256721

Description:

Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus chemotherapy drug can improve progression free survival compared with chemotherapy drug in patients with metastatic the non-small cell lung cancer who failed one lines of chemotherapy.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in NSCLC
  • Official Title: A Randomized, Parallel Control, Exploratory Trial to Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in Subjects With Advanced or Metastatic of the Non-small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: SECGOLC003
  • NCT ID: NCT03256721

Conditions

  • Nonsmall Cell Lung Cancer

Interventions

DrugSynonymsArms
Apatinib/docetaxel/pemetrexedApatinib+docetaxel/pemetrexed
docetaxel/pemetrexeddocetaxel/pemetrexed

Purpose

Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus chemotherapy drug can improve progression free survival compared with chemotherapy drug in patients with metastatic the non-small cell lung cancer who failed one lines of chemotherapy.

Detailed Description

      Lung cancer is the leading cause of cancer death in world wild, especially non-small cell
      lung cancer (NSCLC). Detection and early intervention are difficult because pathogenesis of
      NSCLC is not yet entirely clear.Most of them are advanced or metastatic patients, so approach
      3/4 NSCLC undergo chemotherapy. Fewer treatment options exist on NSCLC whom is wild type of
      EGFR. The patient did not benefit from the existing treatment regimen after first-line
      treatment. There is currently no effective drug to treat this group of patients.

      Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor
      activity in the patients with GC. The purpose of this study is to determine whether apatinib
      plus chemotherapy drug can improve progression free survival compared with chemotherapy drug
      in patients with metastatic the non-small cell lung cancer who failed one lines of
      chemotherapy.
    

Trial Arms

NameTypeDescriptionInterventions
Apatinib+docetaxel/pemetrexedExperimentalApatinib 500mg QD PO d1-21+docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
  • Apatinib/docetaxel/pemetrexed
docetaxel/pemetrexedActive Comparatordocetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
  • docetaxel/pemetrexed

Eligibility Criteria

        Inclusion Criteria:

          1. Age:18~75 years;

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          3. Subjects with histologically or cytologically confirmed locally advanced or advanced
             NSCLC who have previously received no more than one lines treatment before
             participating;

          4. Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which
             is confirmed by computed tomography (CT) scan or MRI .

          5. EGFRˉ,and ALK mutation in the negative or unknown;

          6. Subjects without brain metastases or asymptomatic brain metastases, and not needing
             for dehydrating agents or corticosteroids to control intracranial symptoms;

          7. Survival expectation≥ 3 months;

          8. The main organ function is normal;

          9. Females of childbearing potential must be a pregnancy test in 7 days before
             participating ( including serum or urine), and the results were negative.

         10. Subjects provided written informed consent before participating,Willing and able to
             comply with all aspects of the protocol

        Exclusion Criteria:

          1. Small Cell Lung Cancer;

          2. Subjects with symptomatic brain metastases;

          3. Survival expectation < 3 months;

          4. Blood transfusion is required in the first dose of drug treatment within 14 days ;

          5. The interval of subjects had received chemotherapy, biotherapy, radiotherapy or other
             anticancer therapies in the first dose of drug treatment within 21 days(excluding
             palliative radiotherapy);

          6. The risk of active bleeding;

          7. Subjects with uncontrolled blood pressure with medication (140/90 mmHg)

          8. Laboratory values and organ functions : (1)Hematologic insufficiency:

               1. Hemoglobin (Hb)<8.5 g/dL,

               2. Absolute neutrophil count (ANC)≤1.5×109/L,

               3. Platelet count (PLT)< 100×109/L; (2)Insufficient liver function:

               1. Bilirubin > 1.5×the upper limit of normal (ULN)

               2. Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) >3.0×(ULN),
                  When liver metastases,Bilirubin > 1.5×ULN, ALT or AST >5.0×(ULN.

               3. serum creatinine ≤1.0×(ULN), or creatinine clearance > 50 mL/min( calculated per
                  the Cockcroft and Gault formula) (3) Subjects with positive for HBV
                  surfaceantigen ( HBsAg)or anti-hcv (4)Subjects with Interstitial lung disease
                  (5)Insufficient renal function: serum creatinine≥ 1.5×(ULN), or creatinine
                  clearance <60 mL/min

          9. impairment of heart function: (1)Left ventricular ejection fraction (LVEF) <45% (LVEF
             evaluation is not required for subjects have no history of congestive heart failure),
             (2)Unstable angina, (3)Severe arrhythmia, (4)NYHA III or IVgrade of congestive heart
             failure, (5) Subjects with miocardial infarction within the last 12 months before
             entering the trial, (6)Pericardial effusion,

         10. Subjects with liver fibrosis or hepatic cirrhosis

         11. (1)Subjects with other active malignancy (except for definitively treated non melanoma
             skin cancer,carcinoma in-situ of the cervix,or other cancers that are treated with
             curative treatment and have no signs of recurrence for at least 5 years ) ,
             (2)Subjects with dysphagia,malabsorption,chronic gastrointestinal diseases,or other
             medical history may hinder compliance and / or experimental drug absorption,

         12. Subjects with major surgery in the first dose of drug treatment within 28 days,

         13. Subjects with positive foknown human immunodeficiency virus。
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:progression-free survival
Time Frame:From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Safety Issue:
Description:To compare progression-free survival (PFS) in subjects treated with apatinib plus chemotherapy drug versus chemotherapy drug as a second-line treatment in whom with advanced or metastatic non-small cell lung cancer (NSCLC)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Fuzhou General Hospital

Trial Keywords

  • apatinib docetaxel pemetrexed

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