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Apatinib Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050411
Recruitment Status : Unknown
Verified February 2017 by Li Liang, Peking University Third Hospital.
Recruitment status was:  Recruiting
First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Li Liang, Peking University Third Hospital

Brief Summary:
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently. In this study, the investigators aim to explore the efficacy and reasonable dosage of apatinib combining with EGFR-TKI in advanced non-squamous non-small cell lung cancer with EGFR-TKI resistance.

Condition or disease Intervention/treatment Phase
Nonsmall Cell Lung Cancer Drug: Apatinib Mesylate Tablets Drug: EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib) Phase 1

Detailed Description:

Primary Outcome Measure: efficacy and reasonable dosage of the combination of apatinib and EGFR-TKI in advanced non-squamous non-small cell lung cancer with EGFR-TKI resistance.

Secondary Outcome Measures: Progression free survival, overall survival, Side effects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Apatinib Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
Study Start Date : May 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib
Apatinib in combination with EGFR-TKIs
Drug: Apatinib Mesylate Tablets
250mg, 500mg, 750mg, q.d., p.o.

Drug: EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib)
EGFR-TKIs include but are not limited erlotinib, gefitinib and osimertinib




Primary Outcome Measures :
  1. Optimal Dosage [ Time Frame: 9 months ]
    Optimal dosage of Apatinib which combine with EGFR-TKIs

  2. Progression free survival [ Time Frame: 24 months ]
    PFS is evaluated in 24 months since the treatment begin


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    Overall survival is evaluated in the 24th month since the treatment began

  2. Side effects [ Time Frame: 24 months ]
    Side effects evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0



Information from the National Library of Medicine

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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. Obtain of informed consent.
  2. Histologically or cytologically confirmed, inoperable, recurrence or metastasis advanced non-small cell lung cancer (TNM Stage ⅢB or stage Ⅳ), took EGFR-TKI longer than 6 months and appeared disease progression.
  3. At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors(RESCIST) version 1.1).
  4. Eastern Cooperative Oncology Group(ECOG)Performance Status(PS) :0-2.
  5. Aged from 18 to 75 years (18 and 75 years are included).
  6. Life expectancy ≥12 weeks.
  7. Adequate bone marrow reserve and organ function as follows:

    • Absolute neutrophils count (ANC) ≥1.5 x 10 to the 9th power/L (band neutrophil and segmented neutrophil), platelets > 100 x 10 to the 9th power/L and Hb≥90g/L.
    • Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN).
    • Alkaline phosphatase (AP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 3.0 times ULN (or less than or equal to 5 times ULN in case of known liver involvement.
    • Renal: Serum Creatinine less than or equal to 1.25 times upper limit of normal (ULN).
  8. Have history of hypertension (less than 135/85mmHg).
  9. Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.

Exclusion Criteria:

  1. Do not meet the above criteria.
  2. Prior treatment with VEGFR tyrosine kinase inhibitors or VEGFR targeting agent.
  3. Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery.
  4. Symptomatic Central Nervous System (CNS) metastases.
  5. Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment).
  6. Clinical uncontrolled active infection, such as acute pneumonia, active hepatitis B or C (prior hepatitis B history, despite medication treatment control or not, HBV DNA≥500copies or ≥100IU/ml), etc.
  7. Arterial thrombosis or venous thrombosis in 6 months, or disposition evidence of thrombosis/bleeding in 2 month (despite severity), hemoptysis in 2 weeks (bright red blood, 1/2 teaspoon).
  8. Stroke or transient ischemic attack (TIA) in 12 month.
  9. Unhealed skin lesions, surgical site, injuries, severe mucous membrane ulcer or bone fracture.
  10. Cardiac function evaluation: LVEF <50%, a recent history of MI in 6 months, severe/unstable angina or coronary bypass surgery, or cardiac insufficiency ≥ NYHA 2.
  11. Prior other malignant disease in 5 years (except carcinoma in situ of cervix, or non melanoma skin cancers, or localized prostate cancer with Gleason ≤6).
  12. Documented history of neurological or psychiatric disorders, include epilepsy and dementia.
  13. Recent active digestive disease such as duodenal ulcers, ulcerative colitis, ileus, ect., intestinal perforation, intestine fistula, or other conditions may lead to gastrointestinal bleeding or perforation which regimented at investigators' discretion.
  14. Difficulty swallowing or known malabsorption.
  15. A history of organ transplantation and long-term immunosuppressive medication.
  16. Take part in new drug clinical trials within one month or taking part in a trial now.
  17. Pregnant or lactating woman.
  18. A history of anaphylaxis of apatinib analogue and/or excipient of drugs in this study.
  19. Other conditions regimented at investigators' discretion.

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): NCT03050411


Contacts
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Contact: Li Liang, Prof. M.D. liang.dr@163.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China
Contact: Li Liang, MD    13241870816      
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Chair: Li Liang, Prof. M.D. Peking University Third Hospital
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Responsible Party: Li Liang, Prof. M.D., Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03050411    
Other Study ID Numbers: IRB00006761-2016162
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by Li Liang, Peking University Third Hospital:
Non Small Cell Lung Cancer
EGFR-TKI resistance
Apatinib
anti-angiogenesis drugs
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
Erlotinib Hydrochloride
Apatinib
Gefitinib
Osimertinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action