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A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations

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ClinicalTrials.gov Identifier: NCT03634059
Recruitment Status : Unknown
Verified July 2018 by LiuJunFeng, Hebei Medical University Fourth Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
LiuJunFeng, Hebei Medical University Fourth Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of apatinib plus EGFR-TKI as first line treatment in patients with non-squamous NSCLC harboring EGFR mutation.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Apatinib Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations
Estimated Study Start Date : August 15, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : August 15, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: apatinib
apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po
 Drug: Apatinib
apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: evaluated in two years since the treatment began ]
    Baseline to measured date of progression or death from any cause


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: tumor assessment every 8 weeks，up to two years ]
    Baseline to measured stable disease

  2. Disease control rate (DCR) [ Time Frame: tumor assessment every 8 weeks，up to two years ]
    Baseline to measured progressive disease

  3. Overall survival (OS) [ Time Frame: the first day of treatment to death or last survival confirm date，up to two years ]
    Baseline to measured date of death from any cause

  4. Adverse events [ Time Frame: evaluated in the two years since the treatment began according to the Common Terminology Criteria for Adverse Events Version 4.0 ]
    throughout study


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 to 75 years old (man or female);
  2. Pathologically diagnosed with non-squamous NSCLC;
  3. Imageology diagnosed with locally advanced/metastatic or recurrent (stage ⅢB - IV);
  4. Histologically or cytologic confirmed，harboring an activating EGFR mutation (19del or 21 L858R);
  5. None previous chemotherapy or targeted therapy.（NOTE: neoadjuvant and adjuvant therapy is allowed）;
  6. At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1)；
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

  8. Major organ function has to meet the following criteria:

    1. HB≥90g/L；
    2. ANC≥1.5×109/L；
    3. PLT≥80×109/L；
    4. ALT and AST≤2.5ULN, but≤5ULN if the transferanse elevation is due to liver metastases;
    5. TBIL≤1.5ULN;
    6. Serum creatinine≤1.25ULN; Endogenous creatinine clearance rate>45 ml/min;
  9. Life expectancy greater than or equal to 3 months;
  10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
  11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

  1. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
  2. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;
  3. Radiologically documented evidence of major blood vessel invasion or encasement by cancer;
  4. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
  5. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (++). Has melena and hematemesis in two months;
  6. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency;
  7. Patients with pregnant or planning a pregnancy;
  8. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ);
  9. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
  10. Less than 4 weeks from the last clinical trial;
  11. The researchers think inappropriate.
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): NCT03634059


Contacts
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Contact: Junfeng Liu, Professor 13931152296 13931152296@126.com
Contact: Junfeng Liu 13931152296 13931152296@126.com

Locations
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China, Hebei
Junfeng Liu
Shijiazhuang, Hebei, China, 050000
Contact: Junfeng Liu, Professor    13931152296    13931152296@126.com   
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: Junfeng Liu Hebei Medical University Fourth Hospital
More Information
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Responsible Party: LiuJunFeng, Principal Investigator, Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT03634059    
Other Study ID Numbers: HRA-L01
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action