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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

Tracking Information
First Submitted Date  ICMJE July 12, 2018
First Posted Date  ICMJE August 16, 2018
Last Update Posted Date August 16, 2018
Estimated Study Start Date  ICMJE August 15, 2018
Estimated Primary Completion Date August 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
Progression free survival [ Time Frame: evaluated in two years since the treatment began ]
Baseline to measured date of progression or death from any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • Objective response rate [ Time Frame: tumor assessment every 8 weeks,up to two years ]
    Baseline to measured stable disease
  • Disease control rate (DCR) [ Time Frame: tumor assessment every 8 weeks,up to two years ]
    Baseline to measured progressive disease
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations
Official Title  ICMJE A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE Drug: Apatinib
apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po
Study Arms  ICMJE Experimental: apatinib
apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po
Intervention: Drug: Apatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 14, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2020
Estimated Primary Completion Date August 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03634059
Other Study ID Numbers  ICMJE HRA-L01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LiuJunFeng, Hebei Medical University Fourth Hospital
Study Sponsor  ICMJE Hebei Medical University Fourth Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Junfeng Liu Hebei Medical University Fourth Hospital
PRS Account Hebei Medical University Fourth Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP