This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.
Name: Sequential Icotinib Plus Chemotherapy
Name: Icotinib
Description: A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
Measure: Progression Free Survival Time: 15 monthsDescription: Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Measure: Overall survival Time: 24 monthsDescription: Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measure: Objective response rate Time: 15 monthsDescription: The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Measure: Adverse events Time: 24 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.. Inclusion Criteria: - Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT) - Patients must have previously untreated locally advanced or metastatic NSCLC - EGFR activating mutation (exon 19 deletion, L858R) is required - Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 Exclusion Criteria: - Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR - Patients with wild-type EGFR - Any other investigational agents are not permitted - Any evidence of interstitial lung disease Inclusion Criteria: - Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT) - Patients must have previously untreated locally advanced or metastatic NSCLC - EGFR activating mutation (exon 19 deletion, L858R) is required - Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 Exclusion Criteria: - Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR - Patients with wild-type EGFR - Any other investigational agents are not permitted - Any evidence of interstitial lung disease EGFR Positive Non-small Cell Lung Cancer Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung null --- L858R ---
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.. Inclusion Criteria: - Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT) - Patients must have previously untreated locally advanced or metastatic NSCLC - EGFR activating mutation (exon 19 deletion, L858R) is required - Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 Exclusion Criteria: - Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR - Patients with wild-type EGFR - Any other investigational agents are not permitted - Any evidence of interstitial lung disease Inclusion Criteria: - Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT) - Patients must have previously untreated locally advanced or metastatic NSCLC - EGFR activating mutation (exon 19 deletion, L858R) is required - Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 Exclusion Criteria: - Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR - Patients with wild-type EGFR - Any other investigational agents are not permitted - Any evidence of interstitial lung disease EGFR Positive Non-small Cell Lung Cancer Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung null --- L858R --- --- L858R ---