The main purpose of this study is to evaluate the relapse free survival of patients who have EGFR-mutant stage IIIA-IIIB Non-small Cell Lung Cancer and receive Icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy.
Name: Icotinib
Description: Patients who have EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib with a dose of 125 mg three times per day orally till progressive disease or unaccepted toxicity as consolidation therapy after synchronous or sequential chemoradiotherapy.Type: DrugIcotinib
Description: Relapse Free Survival was defined as the time from randomization to relapse of disease or death from any cause.
Measure: Relapse Free Survival of participants Time: three yearsDescription: Overall survival was defined as the time from participants' randomization to their death due to any cause.
Measure: Overall survival of participants Time: three yearsDescription: 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.
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: three yearsSingle Group Assignment
There is one SNP
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.. Inclusion Criteria: - Unresectable stage IIIA-IIIB Non-small Cell Lung Cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with EGFR 19 del and/or 21 L858R gene mutation detected by amplification refractory mutation system method - Before receiving synchronous or sequential chemoradiotherapy, no metastasis detected by head MRI, bone scan, chest enhanced CT scan and the abdominal (including dual adrenal) enhanced CT scan - Only received synchronous or sequential chemoradiotherapy as anti-tumor treatment; after that, chest enhanced CT showed no progressive disease (including Complete Response, Partial Response and Stable Disease ) - Platinum-based chemotherapy regimen, including: vinorelbine, docetaxel, paclitaxel, pemetrexed, etoposide, etc and combination of platinum (including but not limited to cisplatin and carboplatin) - 3DCRT or IMRT radiotherapy technology with a dose of 95% PTV 60-66gy, 2Gy once daily, 5 times weekly, up to 30-33 times - ECOG score 0-1 - Able to enter the group within 4-12 weeks after the completion of synchronous or sequential chemoradiotherapy - Expected survival more than 12 weeks Exclusion Criteria: - Other malignant tumors within five years, except for completely cured cervical carcinoma, basal or squamous cell carcinoma - In addition to synchronous or sequential chemoradiotherapy, ever received other systemic anti-tumor treatment, including chemotherapy or targeted therapy - Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease - Upper vena cava syndrome at baseline - Idiopathic pulmonary fibrosis detected by CT at baseline - Definite neurological or psychiatric disorders, including epilepsy or dementia - Pregnant or lactating women Inclusion Criteria: - Unresectable stage IIIA-IIIB Non-small Cell Lung Cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with EGFR 19 del and/or 21 L858R gene mutation detected by amplification refractory mutation system method - Before receiving synchronous or sequential chemoradiotherapy, no metastasis detected by head MRI, bone scan, chest enhanced CT scan and the abdominal (including dual adrenal) enhanced CT scan - Only received synchronous or sequential chemoradiotherapy as anti-tumor treatment; after that, chest enhanced CT showed no progressive disease (including Complete Response, Partial Response and Stable Disease ) - Platinum-based chemotherapy regimen, including: vinorelbine, docetaxel, paclitaxel, pemetrexed, etoposide, etc and combination of platinum (including but not limited to cisplatin and carboplatin) - 3DCRT or IMRT radiotherapy technology with a dose of 95% PTV 60-66gy, 2Gy once daily, 5 times weekly, up to 30-33 times - ECOG score 0-1 - Able to enter the group within 4-12 weeks after the completion of synchronous or sequential chemoradiotherapy - Expected survival more than 12 weeks Exclusion Criteria: - Other malignant tumors within five years, except for completely cured cervical carcinoma, basal or squamous cell carcinoma - In addition to synchronous or sequential chemoradiotherapy, ever received other systemic anti-tumor treatment, including chemotherapy or targeted therapy - Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease - Upper vena cava syndrome at baseline - Idiopathic pulmonary fibrosis detected by CT at baseline - Definite neurological or psychiatric disorders, including epilepsy or dementia - Pregnant or lactating women EGFR Gene Mutation Non Small Cell Lung Cancer Stage IIIA Non Small Cell Lung Cancer Stage IIIB Lung Neoplasms Carcinoma, Non-Small-Cell Lung This is a single center, single arm, open label and prospective clinical study. --- L858R ---
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.. Inclusion Criteria: - Unresectable stage IIIA-IIIB Non-small Cell Lung Cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with EGFR 19 del and/or 21 L858R gene mutation detected by amplification refractory mutation system method - Before receiving synchronous or sequential chemoradiotherapy, no metastasis detected by head MRI, bone scan, chest enhanced CT scan and the abdominal (including dual adrenal) enhanced CT scan - Only received synchronous or sequential chemoradiotherapy as anti-tumor treatment; after that, chest enhanced CT showed no progressive disease (including Complete Response, Partial Response and Stable Disease ) - Platinum-based chemotherapy regimen, including: vinorelbine, docetaxel, paclitaxel, pemetrexed, etoposide, etc and combination of platinum (including but not limited to cisplatin and carboplatin) - 3DCRT or IMRT radiotherapy technology with a dose of 95% PTV 60-66gy, 2Gy once daily, 5 times weekly, up to 30-33 times - ECOG score 0-1 - Able to enter the group within 4-12 weeks after the completion of synchronous or sequential chemoradiotherapy - Expected survival more than 12 weeks Exclusion Criteria: - Other malignant tumors within five years, except for completely cured cervical carcinoma, basal or squamous cell carcinoma - In addition to synchronous or sequential chemoradiotherapy, ever received other systemic anti-tumor treatment, including chemotherapy or targeted therapy - Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease - Upper vena cava syndrome at baseline - Idiopathic pulmonary fibrosis detected by CT at baseline - Definite neurological or psychiatric disorders, including epilepsy or dementia - Pregnant or lactating women Inclusion Criteria: - Unresectable stage IIIA-IIIB Non-small Cell Lung Cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with EGFR 19 del and/or 21 L858R gene mutation detected by amplification refractory mutation system method - Before receiving synchronous or sequential chemoradiotherapy, no metastasis detected by head MRI, bone scan, chest enhanced CT scan and the abdominal (including dual adrenal) enhanced CT scan - Only received synchronous or sequential chemoradiotherapy as anti-tumor treatment; after that, chest enhanced CT showed no progressive disease (including Complete Response, Partial Response and Stable Disease ) - Platinum-based chemotherapy regimen, including: vinorelbine, docetaxel, paclitaxel, pemetrexed, etoposide, etc and combination of platinum (including but not limited to cisplatin and carboplatin) - 3DCRT or IMRT radiotherapy technology with a dose of 95% PTV 60-66gy, 2Gy once daily, 5 times weekly, up to 30-33 times - ECOG score 0-1 - Able to enter the group within 4-12 weeks after the completion of synchronous or sequential chemoradiotherapy - Expected survival more than 12 weeks Exclusion Criteria: - Other malignant tumors within five years, except for completely cured cervical carcinoma, basal or squamous cell carcinoma - In addition to synchronous or sequential chemoradiotherapy, ever received other systemic anti-tumor treatment, including chemotherapy or targeted therapy - Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease - Upper vena cava syndrome at baseline - Idiopathic pulmonary fibrosis detected by CT at baseline - Definite neurological or psychiatric disorders, including epilepsy or dementia - Pregnant or lactating women EGFR Gene Mutation Non Small Cell Lung Cancer Stage IIIA Non Small Cell Lung Cancer Stage IIIB Lung Neoplasms Carcinoma, Non-Small-Cell Lung This is a single center, single arm, open label and prospective clinical study. --- L858R --- --- L858R ---