Status:
UNKNOWN
Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
EGF-R Positive Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 surge...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03749213
Start Date
December 1 2018
End Date
December 30 2024
Last Update
November 21 2018
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Science
Beijing, China