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

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ClinicalTrials.gov Identifier: NCT03256721
Recruitment Status : Terminated (Due to the enrollment was slow and exceeded the expected enrollment time)
First Posted : August 22, 2017
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Fuzhou General Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nonsmall Cell Lung Cancer Drug: Apatinib/docetaxel/pemetrexed Drug: docetaxel/pemetrexed Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Group A: Apatinib 500mg QD PO d1-21 + Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d

Group B: Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : August 16, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Apatinib+docetaxel/pemetrexed
Apatinib 500mg QD PO d1-21+docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
 Drug: Apatinib/docetaxel/pemetrexed
Participants are randomly assigned to treatment group or control group
Active Comparator: docetaxel/pemetrexed
docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
 Drug: docetaxel/pemetrexed
Participants are randomly assigned to treatment group or control group


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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。
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256721


Locations
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China, Fujian
Fuzhou general hospital
Fuzhou, Fujian, China, 365000
Sponsors and Collaborators
Fuzhou General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT03256721    
Other Study ID Numbers: SECGOLC003
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fuzhou General Hospital:
apatinib docetaxel pemetrexed
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
 Pemetrexed
Apatinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors