Back to resultsIcotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer
Primary Purpose
EGF-R Positive Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib
Sponsored by
About this trial
This is an interventional treatment trial for EGF-R Positive Non-Small Cell Lung Cancer
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 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
Sites / Locations
- Cancer Hospital, Chinese Academy of Medical ScienceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Icotinib
Arm 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 as neoadjuvant therapy before surgery and adjuvant therapy or till progressive disease or unaccepted toxicity.
Outcomes
Primary Outcome Measures
Objective Response Rate
Secondary Outcome Measures
R0 resection rate
Disease Control Rate
Decrease in cT-stage
pathologic complete remission rate
Time to Tumor Progression
Overall survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
NCT ID
NCT03749213
First Posted
November 19, 2018
Last Updated
November 19, 2018
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03749213
Brief Title
Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer
Official Title
Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer: a Single Arm, Phase II Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EGF-R Positive Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Icotinib
Arm Type
Experimental
Arm 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 as neoadjuvant therapy before surgery and adjuvant therapy or till progressive disease or unaccepted toxicity.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
Conmana
Intervention 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 before surgery and for 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.
Primary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
R0 resection rate
Time Frame
eight weeks
Title
Disease Control Rate
Time Frame
eight weeks
Title
Decrease in cT-stage
Time Frame
eight weeks
Title
pathologic complete remission rate
Time Frame
eight weeks
Title
Time to Tumor Progression
Time Frame
five years after surgery
Title
Overall survival
Time Frame
five years after surgery
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
five years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shugeng Gao, MD
Phone
13801185056
Email
gaoshugeng@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shugeng Gao
Organizational Affiliation
Cancer Hospital, Chinese Academy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Science
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shugeng Gao, MD
First Name & Middle Initial & Last Name & Degree
Shugeng Gao, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer
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