Clinical Trials /

Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

NCT03203590

Description:

The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC patients with EGFR mutation.

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

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients
  • Official Title: Oral Navelbine Carboplatin Versus Gefitinib Neoadjuvant Therapy for Resectable EGFR Mutation Positive Stage Ⅱ-ⅢA NSCLC, Prospective, Randomized, Multicenter, Phase Ⅲ Clinical Trial

Clinical Trial IDs

  • ORG STUDY ID: 3939366
  • NCT ID: NCT03203590

Conditions

  • 2-year Disease-Free Survival

Interventions

DrugSynonymsArms
Oral Navelbine + CarboplatinVinorelbine, CarboplatOral Navelbine + Carboplatin
GefitinibIressaGefitinib

Purpose

The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC patients with EGFR mutation.

Detailed Description

      Lung cancer is the most common cause of cancer mortality in men and women in the world. LACE
      meta analysis shows that the 5-year survival rate of post-operation chemotherapy group rose
      by 5.4%, therefore, adjuvant chemotherapy has been the main treatment after surgery according
      to National Comprehensive Cancer Network (NCCN) Guideline. But patients have poor compliance
      due to physical condition after surgery. Compared with adjuvant chemotherapy, neoadjuvant
      therapy has better patient compliance and tolerance.Targeted therapy, with milder side effect
      compared with chemotherapy, may be a promising choice to treat NSCLC previously. But to date,
      there is no enough evidence to support the efficacy and safety of neoadjuvant targeted
      therapy in patients with EGFR mutation.The purpose of this study is to evaluate the
      efficiency and safety of Gefitinib Neoadjuvant Therapy vs Oral Navelbine Carboplatin
      Neoadjuvant Therapy for Resectable NSCLC patients harboring EGFR mutation.
    

Trial Arms

NameTypeDescriptionInterventions
Oral Navelbine + CarboplatinActive ComparatorNeoadjuvant therapy Patients with EGFR mutation will be recruited and treated with Navelbine + Carboplatin.
  • Oral Navelbine + Carboplatin
GefitinibExperimentalNeoadjuvant therapy Patients with EGFR mutation will be recruited and treated with gefitinib.
  • Gefitinib

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologic diagnosis of non small cell lung cancer, Stage Ⅱ-ⅢA before treatment

          -  EGFR Gene mutated

          -  ECOG 0-1

          -  liver, kidney and bone marrow are functional healthy,WBC>4.0×109/L,PLT>100×109/L
             Hb>10g/dL;Cr<1.8mg/dL,bilirubin<1.5mg/dL,GPT<1.5 upper limit of normal

          -  No vital systems dysfunction or malnutrition

          -  No other malignant diseases in 5 years(except non melanoma or Cervical carcinoma in
             situ)

          -  Have never accepted radiation therapy、overall chemotherapy or biotherapy

          -  Know the whole protocol,Voluntary participate and sign a consent form

        Exclusion Criteria:

          -  Tumor has violated the surrounding tissue organs(T4)

          -  Preoperative have evidence of distant metastasis including the contralateral
             mediastinal lymph nodes

          -  Arrhythmia need anti-arrhythmic treatment(except for β-blockers or
             digoxin),Symptomatic coronary artery disease and myocardial ischemia (myocardial
             infarction) in the past 6 months or more than NYHA class II congestive heart failure

          -  Adverse drug control severe hypertension

          -  Moderate to severe proteinuria

          -  History of HIV infection or activity of chronic hepatitis b or hepatitis c, or other
             active clinical severe infection

          -  Cachexy,organ function decompensation

          -  History of chest radiotherapy

          -  Not fully control the eye inflammation

          -  Epilepsy patients needed treatment(such as Steroids or antiepileptic cure)

          -  Interstitial pneumonia

          -  Drug abuse and medical, psychological or social conditions may interfere with the
             patients involved in the research or have an impact on the results of evaluation

          -  Known or suspected to study drug allergy or to give any drug allergies associated with
             this test

          -  Any unstable situation or may endanger the patient safety and compliance

          -  Fertility and pregnancy or lactation women, and have not been sufficient precautions
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:2-year disease free survival
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate
Time Frame:1 week before surgery
Safety Issue:
Description:
Measure:Pathologic complete response
Time Frame:Within 1 month after surgery
Safety Issue:
Description:
Measure:Side effects
Time Frame:1 week before surgery
Safety Issue:
Description:
Measure:Standard uptake value
Time Frame:1 week before surgery
Safety Issue:
Description:
Measure:Tumor reduction rate
Time Frame:Within 1 month after surgery
Safety Issue:
Description:
Measure:Mediastinal lymph nodes clearance
Time Frame:Within 1 month after surgery
Safety Issue:
Description:
Measure:Postoperative complications
Time Frame:Within 1 month after discharge
Safety Issue:
Description:
Measure:R0 resection rate
Time Frame:Within 1 month after surgery
Safety Issue:
Description:
Measure:Postoperative mortality rate
Time Frame:Within 1 month after discharge
Safety Issue:
Description:
Measure:5-year overall survival
Time Frame:5 years after surgery
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sun Yat-sen University

Last Updated