Clinical Trials /

Retreatment With Epidermal Growth Factor Receptor(EGFR) Tyrosine Kinase Inhibitor in EGFR Mutation Positive Patients

NCT03382795

Description:

In this trial, treatment efficacy and safety of retreatment with 1st generation epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor(TKI)s(Gefitinib/Erlotinib), will be assessed in patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously treated with EGFR TKI and cytotoxic chemotherapy

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Retreatment With Epidermal Growth Factor Receptor(EGFR) Tyrosine Kinase Inhibitor in EGFR Mutation Positive Patients
  • Official Title: Retreatment With 1st Generation EGFR TKIs in Sensitizing EGFR Mutation Positive Non-Squamous Cell Carcinoma Patients Who Previously Treated With EGFR TKI and Cytotoxic Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: KUGH17195 (EGFR retreatment)
  • NCT ID: NCT03382795

Conditions

  • EGFR Positive Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
EGFREGFR retreat group

Purpose

In this trial, treatment efficacy and safety of retreatment with 1st generation epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor(TKI)s(Gefitinib/Erlotinib), will be assessed in patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously treated with EGFR TKI and cytotoxic chemotherapy

Detailed Description

      This study is designed to be multi-center, open-label, single-arm, prospective, phase II
      trial of patient with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients
      who previously treated with EGFR TKI and cytotoxic chemotherapy. Approximately 69 patients
      will be enrolled into the trial, and expected study duration is 24 months from Institutional
      Review Board(IRB) and Korea Ministry of Food and Drug Safety(MFDS) approval date.

      The study drug will be administered orally as one tablet(Gefitinib 250mg/ Erlotinib 150mg)
      once a day until disease progression or manifestation of unacceptable toxicity. The initial
      dose of the study drug daily can be reduced according to dose reduction criteria in protocol.
      A cycle of study treatment is defined as 28 days, and subjects will visit the site every 2
      cycles(56 days).
    

Trial Arms

NameTypeDescriptionInterventions
EGFR retreat groupExperimental
  • EGFR

Eligibility Criteria

        Inclusion Criteria:

          1. Males or females ≥ 19 years of age

          2. Non Small Cell Lung Cancer(Non-Squamous Cell Carcinoma) patients who had shown
             clinical benefits (Complete response(CR) or Partial response(PR) or Stable disease(SD)
             ≥6 months) from EGFR-TKIs as first line treatment and developed progressive disease,
             and then received cytotoxic chemotherapy more than 4 cycles and developed progressive
             disease, and then confirmed methionine for threonine at amino acid position 790(T790M)
             negative and sensitizing EGFR mutation positive in Histologic or cytologic specimen.

          3. Patient with at least one measurable lesions according to RECIST v 1.1

          4. Expected life expectancy ≥ 12 weeks

          5. Eastern Cooperative Oncology Group(ECOG) performance status ≤ 2

          6. Patients who have proper hematologic, renal and hepatic functions as follows:

               -  Absolute neutrophil count(ANC) ≥ 1,500/mm³

               -  platelets ≥ 100,000/mm³

               -  Hemoglobin ≥ 9g/dL

               -  Total bilirubin ≤ 1.25 X UNL

               -  Aspartate aminotransferase(AST or SGOT) and alanine aminotransferase(ALT or SGPT)
                  ≤ 3.0 X UNL (if liver metastasis ≤5.0 X UNL)

               -  Alkaline phosphatase ≤ 2.5 X UNL (if liver metastasis ≤5.0 X UNL)

               -  Serum creatinine ≤ 1.5mg/dL

          7. patients who are willing to comply with study procedure and voluntarily provide
             informed consent with signature

        Exclusion Criteria:

          1. Patients who have preexisting or coexisting malignancies in other parts except for
             effectively treated non-melanoma skin cancer, cervical carcinoma in situ(CIS) cervical
             cancer within the last 5 years

          2. Patients with central nervous system(CNS) metastasis

          3. Patients currently receiving palliative radiation therapy or have toxicities from
             radiation therapy at screening.

          4. Patients with clinically active history of interstitial lung disease(ILD), Drug
             induced ILD, Radiation pneumonitis

          5. Patients with clinically significant cardiovascular disease or myocardial infarction
             within the past 12 months.

          6. Patients with active infection or severe systemic disease that are difficult to
             include in this study

          7. Patients who received radiation therapy to target lesion of this study.

          8. Patients who had major operation within 4 weeks before starting the study treatment
             and were not fully recovered.

          9. Patients who were administered other study drugs within 4 weeks before starting the
             study treatment

         10. Males and females of reproductive potential who are not using an effective method of
             birth control and females who are pregnant or breastfeeding or have a positive
             pregnancy test prior to study entry

         11. Patients who are difficult to include in this study in accordance with the
             investigator's judgment

         12. Patients with histories of hypersensitivity to investigational product(IP) or any
             components of the agent

         13. Patients with any of the following genetic predispositions including galactose
             intolerance, Lapp lactase deficiency, lactose intolerance or glucose-galactose
             malabsorption

         14. Patient previously received cytotoxic chemotherapy within 2 weeks of IP administration

         15. Patient received Immunotherapy prior to the study participation

         16. Patients who are difficult to include in this study in accordance with the
             investigator's judgment due to severe adverse effects during previous EGFR TKI
             treatment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate(ORR) including rage of CR&PR
Time Frame:Through study completion (2 years)
Safety Issue:
Description:Assessed on based of RECIST 1.1.

Secondary Outcome Measures

Measure:Progression Free Survival, PFS
Time Frame:Through study completion (2 years)
Safety Issue:
Description:Progression-free survival (PFS) the time from first dose of the study drug until the date of disease progression or death by any cause
Measure:Overall Survival
Time Frame:Through study completion (2 years)
Safety Issue:
Description:Overall Survival (OR) the time from first dose of the study drug until the date of death by any cause
Measure:The incidence of Adverse Events(including Serious Adverse Events and Adverse Drug Reactions)
Time Frame:Through study completion (2 years)
Safety Issue:
Description:Assessment on the base of NCI-CTCAE (version 4.03)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Korea University Guro Hospital

Trial Keywords

  • Epidermal growth factor receptor tyrosine kinase inhibitor
  • Cytotoxic chemotherapy
  • Epidermal growth factor receptor mutation

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