Clinical Trials /

Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer

NCT03349203

Description:

The main purpose of this study is to evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy in EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer
  • Official Title: Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer: a Single Arm, Phase II Clinical Study

Clinical Trial IDs

  • ORG STUDY ID: BD-IC-IV81
  • NCT ID: NCT03349203

Conditions

  • EGF-R Positive Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
IcotinibConmanaIcotinib

Purpose

The main purpose of this study is to evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy in EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery.

Detailed Description

      Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can
      be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125
      mg three times per day orally for 8 weeks as neoadjuvant therapy; then they receive surgical
      resection of the tumor. If there is curative effect of Icotinib according to the RECIST or
      pathological report, the patients will continue receive Icotinib for two years as adjuvant
      therapy after surgery or till progressive disease or unaccepted toxicity. The primary
      objective of this study is evaluate the pulmonary and metastases lesions objective response
      rate after Icotinib preoperative therapy.
    

Trial Arms

NameTypeDescriptionInterventions
IcotinibExperimentalPatients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks before surgery and 2 years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity.
  • Icotinib

Eligibility Criteria

        Inclusion Criteria:

          -  Histology or cytology confirmed Non-small Cell Lung Cancer; EGFR mutation (EGFR 19del
             and/or 21L858R) detected by tumor tissue biopsy of primary lesion or metastatic lesion
             or plasma ctDNA

          -  No previous anti-tumor treatment such as surgery, chemotherapy, radiotherapy or
             biological therapy

          -  Stage IIIB or IV Oligometastasis Non-small Cell Lung Cancer. (a) stage IV
             Oligometastasis: the metastasis organ mainly include: 1. adrenal metastasis which can
             be potentially resected by surgery or radically treated by SRS radiotherapy; 2. brain
             metastasis which can be potentially resected by surgery or radically treated by SRS
             radiotherapy. At the same time, the primary lesion of the lung can be completely
             removed, which should be T1-2, N0-1 or T3, N0. (b) stage IIIB (T1-3, N3): it is
             limited to patients who are unsuitable or refuse to accept pulmonary primary lesion
             radiotherapy. It only include subclavian lymph node or anterior scalenus lymph node
             metastasis (mediastinal lymph node metastasis is excluded by PET-CT). The metastasis
             lesion should be single or less than 3, its diameter is no more than 3 cm and can be
             potentially resected.

          -  Sufficient tumor histological specimens (non-cytology) for molecular marker analysis

          -  At least one lesion with measurable diameter and its longest diameter is large than 10
             mm by CT measurement

        Exclusion Criteria:

          -  Previous systemic anti-tumor treatment of Non-small Cell Lung Cancer, including
             cytotoxic drug therapy, targeted drug therapy (tyrosine kinase inhibitors or
             monoclonal antibodies) and experimental treatment, etc

          -  Previous local radiotherapy of Non-small Cell Lung Cancer

          -  Be allergic to any component of Icotinib tablet (Conmana)

          -  Other cancers within five years prior to the treatment of this study. Except for
             cervical carcinoma, basal cell carcinoma and bladder epithelial neoplasm (including Ta
             and Tis)

          -  Any instable systemic disease, including: active infection, high blood pressure out of
             control, unstable angina, onset of angina pectoris within the past 3 months,
             congestive heart failure, myocardial infarction, severe arrhythmia, liver, kidney or
             metabolic disease

          -  Previous interstitial lung disease, drug-induced interstitial disease, radiation
             pneumonia requiring hormone therapy or any active intersexual lung disease with
             clinical evidence

          -  Idiopathic pulmonary fibrosis detected by CT scan at baseline;

          -  Not fully controlled eye inflammation or infections, or any condition that may lead to
             the above eye diseases

          -  Human immunodeficiency virus infection

          -  Patients undergoing major surgery or severe trauma within 2 months prior to the first
             use of the experimental drug

          -  Patients with Small Cell Lung Cancer

          -  Pregnant or lactating women

          -  Neurological or psychiatric disorders history, including epilepsy or dementia

          -  Other situations not appropriate to enter the group considering by the investigators
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate as assessed by RECIST1.1
Time Frame:eight weeks
Safety Issue:
Description:Objective Response Rate was defined as the percentage of participants whose tumor lesions disappear completely or diameters reduced by at least 30% as assessed by RECIST1.1.

Secondary Outcome Measures

Measure:Disease Control Rate as assessed by RECIST1.1
Time Frame:five years after surgery
Safety Issue:
Description:Disease Control Rate was defined as the total percentage of participants except for those with tumor lesions diameters increased by at least 20% as assessed by RECIST1.1.
Measure:Time to Tumor Progression as assessed by RECIST1.1
Time Frame:five years after surgery
Safety Issue:
Description:Time to Tumor Progression was defined as the time between participants' randomization and their tumor progression as assessed by RECIST1.1.
Measure:Overall survival of participants
Time Frame:five years after surgery
Safety Issue:
Description:Overall survival was defined as the time from participants' randomization to their death due to any cause.
Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame:five years after surgery
Safety Issue:
Description:The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 would be recorded and calculated after them participating into the study and taking the experimental drug.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Betta Pharmaceuticals Co.,Ltd.

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