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.
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.
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
