Clinical Trials /

NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.

NCT02347839

Description:

The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable stage III NSCLC harboring EGFR mutations.

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

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02347839

Trial Eligibility

Document

Title

  • Brief Title: NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.
  • Official Title: A Multicenter Phase II Trial of Neoadjuvant Gefitinib Followed by Surgery, Followed by Adjuvant Gefitinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutations.

Clinical Trial IDs

  • ORG STUDY ID: GASTO1004
  • SECONDARY ID: wsy005
  • NCT ID: NCT02347839

Conditions

  • Lung Cancer

Purpose

The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable stage III NSCLC harboring EGFR mutations.

Detailed Description

      Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with
      unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance
      of cure. With combined-modality therapy with radiation therapy and chemotherapy, the
      prognosis of stage III NSCLC remains poor. Gefitinib has shown great efficacy in NSCLC
      patients with EGFR mutations. This study is to studying neoadjuvant gefitinib followed by
      surgery, followed by adjuvant gefitinib to see how well it works in treating patients with
      unresectable EGFR mutant stage III NSCLC.

Trial Arms

NameTypeDescriptionInterventions
Intervention groupExperimentalGefitinib-surgery-gefitinib. Induction gefitinib therapy was given for 8 weeks. Patients' resectability was assessed after 8-week gefitinib. Adjuvant gefitinib was given within 3-6 weeks after surgery until progression or unacceptable toxic effects.

    Eligibility Criteria

            Inclusion Criteria:

          -  Target population is unresectable stage III (III A-bulky N2, III B) NSCLC with EGFR
             activating mutation in exon 19 or 21

          -  Written informed consent provided

          -  Aged 18-75 years

          -  Able to comply with the required protocol and follow-up procedures

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Had a life expectancy of 12 weeks or more

          -  Adequate hematological function, liver function and renal function

          -  Female participants should not be pregnant or breast-feeding

        Exclusion Criteria:

          -  Known severe hypersensitivity to gefitinib or any of the excipients of this product

          -  Inability to comply with protocol or study procedures

          -  Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g.
             erlotinib, gefitinib, cetuximab, trastuzumab)

          -  Had a history another malignancy in the last 5 years with the exception of cured basal
             cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured
             epithelial carcinoma of the bladder

          -  Interstitial pneumonia

          -  Eye inflammation not fully controlled or conditions predisposing the subject to this

          -  Any unstable systemic disease (including active infection, uncontrolled hypertension,
             unstable angina, congestive heart failure, myocardial infarction within the previous
             year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic
             disease)

          -  Known human immunodeficiency virus (HIV) infection

          -  Pregnancy or breast-feeding women

          -  History of neurologic or psychiatric disorders

          -  Ingredients mixed with small cell lung cancer patients
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Resectability rate
    Time Frame:3 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Number of participants with perioperative complications
    Time Frame:1 year
    Safety Issue:
    Description:
    Measure:Event-free survival
    Time Frame:2 years after the last patient is randomized
    Safety Issue:
    Description:Event-free survival was assessed from randomization to disease recurrence/progression or death from any cause.
    Measure:Overall survival
    Time Frame:2 years after the last patient is randomized
    Safety Issue:
    Description:Overall survival was assessed from randomization to death from any cause.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Sun Yat-sen University

    Last Updated

    April 20, 2018