Clinical Trials /

Apatinib in the Treatment of Patients With EGFR T790M-Negative NSCLC

NCT03389256

Description:

This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy.

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

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Apatinib in the Treatment of Patients With EGFR T790M-Negative NSCLC
  • Official Title: A Randomized, Controlled Phase II Clinical Trial of Apatinib in Combination With EGFR-TKI Versus EGFR-TKI for Non-squamous, Non-small Cell Lung Cancer(NSCLC) With T790M-negative After the Failure of EGFR-TKI Therapy

Clinical Trial IDs

  • ORG STUDY ID: APTN-NSCLC-201712
  • NCT ID: NCT03389256

Conditions

  • Lung Diseases
  • Neoplasms
  • Respiratory Tract Diseases
  • Thoracic Neoplasms
  • Non-Small-Cell Lung

Interventions

DrugSynonymsArms
Apatinibapatinib tabletsapatinib combine with EGFR-TKI
EGFR-TKIImatinibGefitinib or Erlotinibapatinib combine with EGFR-TKI

Purpose

This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy.

Trial Arms

NameTypeDescriptionInterventions
apatinib combine with EGFR-TKIExperimentalEvery 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity
  • Apatinib
  • EGFR-TKI
EGFR-TKIActive ComparatorEvery 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity
  • EGFR-TKI

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically confirmed stage IIIB, IV non-squamous non-small cell lung cancer, with
             measurable lesions (the long axis of tumor lesions ≥ 10mm with CT, the short axis of
             lymph node lesions ≥ 15mm with CT, the lesions not receive radiotherapy, frozen or
             other local treatment);

          -  Patients with slow progression on first-line EGFR TKI(erlotinib / icotinib /
             gefitinib) treatment;

          -  No T790M mutation including an assessment from tumor biopsy obtained while on or
             subsequent to the most recent EGFR TKI therapy;

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2;

          -  Life expectancy of more than 3 months;

          -  Adequate bone marrow function: WBC ≥ 3.0 ×10 E+9/L, neutrophil ≥ 1.5 × 10 E+9/L,
             platelets ≥ 80 × 10E+9/L,Hb ≥ 10.0g/dL;a total bilirubin (TBil) of ≤1.5 upper normal
             limitation (UNL), a alanine aminotransferase (ALAT) and aspartate aminotransferase
             (ASAT) of ≤3UNL or ≤5UNL in case of liver metastasis, a creatinine (Cr) of ≤ 1.5 UNL;
             a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault);

          -  Female subjects of child-bearing potential must agree to use contraceptive measures
             starting 1 week before the administration of the first dose of apatinib until 8 weeks
             after discontinuing study drug. Male subjects must agree to use contraceptive measures
             during the study and 8 weeks after last dose of study drug;

          -  the participants volunteered to join this study should sign the informed consent
             forms, have better compliance in the follow-up;

        Exclusion Criteria:

          -  Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma
             (including small cell carcinoma and non-small cell mixed lung carcinoma);

          -  Active brain metastases, cancerous meningitis, patients with spinal cord compression;

          -  Rapid progression of the disease or cancer invades vital organs;

          -  The distance between the tumor lesion and the large blood vessel is less than 5 mm, or
             there is a central tumor invading local macrovascular;

          -  obvious pulmonary cavity or tumor necrosis;

          -  Uncontrollable high blood pressure;

          -  Grade Ⅱ or above myocardial ischemia or myocardial infarction or arrhythmia control is
             not good,Ⅲ ~ Ⅳ grade cardiac insufficiency, or cardiac ultrasonography showed left
             ventricular ejection fraction (LVEF) <50% according to the NYHA standard;

          -  Have a history of interstitial lung disease or patients with interstitial lung
             disease;

          -  Coagulation abnormalities (INR> 1.5 or PT> ULN + 4s or APTT> 1.5 ULN) with bleeding
             tendency or undergoing thrombolytic or anticoagulant therapy;

          -  There was significant hemoptysis within 2 months prior to enrollment, or a daily
             hemoptysis volume is 2.5 ml or above;

          -  A clinically significant bleeding symptom or bleeding tendencies such as
             gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above,
             or vasculitis that occurred within 3 months prior to enrollment;

          -  Aneurysm / venous thrombotic events such as cerebrovascular accident (including
             transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein
             thrombosis and pulmonary embolism;

          -  Arterial / venous thrombotic events such as cerebrovascular accidents (including
             transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein
             thrombosis and pulmonary embolism within 12 months prior to enrollment;

          -  Hereditary or acquired bleeding and thrombophilia, such as hemophilia, coagulopathy,
             thrombocytopenia, hypersplenism;

          -  Long-term unhealed wounds or fractures;

          -  Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks prior to
             enrollment;

          -  Unable to swallow, chronic diarrhea or intestinal obstruction;

          -  Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months
             prior to enrollment;

          -  Urinary protein ≥ ++, 24-hour urinary protein ≥ 1.0 g;

          -  Active infections require antimicrobial treatment;

          -  ALK gene abnormalities (gene fusion or mutation occurred);

          -  Pregnant or lactating women, or women unwilling or unable to take effective
             contraception;
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:up to 24 months
Safety Issue:
Description:the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:up to 36 months
Safety Issue:
Description:The length of time from either the date of diagnosis or the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.
Measure:Duration of response (DOR)
Time Frame:up to 24 months
Safety Issue:
Description:From first response to the date of first documented disease progression
Measure:Disease Control Rate (DCR)
Time Frame:24 weeks
Safety Issue:
Description:the proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator.
Measure:Overall response rate (ORR)
Time Frame:24 weeks
Safety Issue:
Description:the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator
Measure:the quality of life (QoL)
Time Frame:up to 36 months
Safety Issue:
Description:Analysis of changes from baseline using the quality of life (QoL) instrument

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sichuan Cancer Hospital and Research Institute

Trial Keywords

  • apatinib
  • T790 negative
  • NSCLC

Last Updated