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Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749213
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Brief Summary:
The main purpose of this study is to evaluate the efficacy and safety of Icotinib as neoadjuvant in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery.

Condition or disease Intervention/treatment Phase
EGF-R Positive Non-Small Cell Lung Cancer Drug: Icotinib Phase 2

Detailed Description:
Patients with EGFR-mutant Stage ⅢA-N2 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 patients with clinical benefits 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 efficacy and safety of Icotinib neoadjuvant therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer: a Single Arm, Phase II Clinical Study
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Icotinib
Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib as neoadjuvant therapy before surgery and adjuvant therapy or till progressive disease or unaccepted toxicity.
Drug: Icotinib
Patients with EGFR-mutant Stage ⅢA-N2 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 before surgery and for 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.
Other Name: Conmana




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: eight weeks ]

Secondary Outcome Measures :
  1. R0 resection rate [ Time Frame: eight weeks ]
  2. Disease Control Rate [ Time Frame: eight weeks ]
  3. Decrease in cT-stage [ Time Frame: eight weeks ]
  4. pathologic complete remission rate [ Time Frame: eight weeks ]
  5. Time to Tumor Progression [ Time Frame: five years after surgery ]
  6. Overall survival [ Time Frame: five years after surgery ]
  7. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: five years after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 IIIA N2 NSCLC according to the pathological evidence of endobronchial ultrasound(EBUS) or PET-CT, the short-axis diameter of lymph node 1-2cm, and considered surgically resectable at baseline by the surgical oncologist
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749213


Contacts
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Contact: Shugeng Gao, MD 13801185056 gaoshugeng@vip.sina.com

Locations
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China
Cancer Hospital, Chinese Academy of Medical Science Recruiting
Beijing, China
Contact: Shugeng Gao, MD         
Principal Investigator: Shugeng Gao, MD         
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Shugeng Gao Cancer Hospital, Chinese Academy of Medical Science
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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03749213    
Other Study ID Numbers: BD-IC-IV82
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms