Efficacy of Targeted Therapy Combined Chemotherapy in Advanced EGFR Positive NSCLC Patients
Condition: Non-small-lung-cell Cancer; NSCLC; EGFR Gene Mutation
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      This study is a randomized, multicenter clinical study ，which is designed to compare the
      efficacy of the safety and efficacy of treatment every 6 weeks in EGFR positive (Non-small
      cell lung cancer, NSCLC) with concurrent Driver gene mutations，who used EGFR-TKI with or
      without combined chemotherapy，estimated with stable efficacy (CR, PR, and SD) .In this study,
      subjects will be randomly assigned to the following two groups according to a 1:1 ratio:(A)
      Standard programme group, EGFR-TKI targeted therapy; (B) controlled programme group, EGFR-TKI
      targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )
    

Detailed description: 
      This study is a randomized, multicenter clinical study aimed at EGFR positive non-small-cell
      lung cancer (NSCLC) subjects with concurrent Driver gene mutations who have not previously
      received systematic treatment. After comparing EGFR-TKI alone or EGFR-TKI combined with
      chemotherapy for 4 cycles, after the efficacy evaluation was stable (CR, PR, and SD), the
      safety and clinical efficacy of maintenance therapy every 6 weeks were compared. The eligible
      subjects in this study will be randomly assigned into the following two groups according to
      the 1: 1 ratio: (A) Standard programme group, EGFR-TKI targeted therapy; (B) controlled
      programme group, EGFR-TKI targeted therapy combined chemotherapy (pemetrexed plus carboplatin
      for 4 cycles ) During the course of the trial treatment, if the subject develops disease (the
      first PD), the researcher will decide whether to continue the medication according to the
      patient's situation and communicate with the patient, as follows: After the first PD of the
      subject, the researcher decides whether to continue the treatment with the original regimen
      according to the disease state of the subject. At least 4 weeks later, the tumor is evaluated
      again. If the tumor progresses again (the second PD), the subject's study treatment ends and
      the follow-up period is entered; if there is no progress, the original regimen is continued.

      The primary end point was descriptive analysis of progression-free survival and Objective
      response rate.The secondary end point of this study was to compare the incidence of
      treatment-related grade 3-5 adverse events between the standard group and the controlled
      group. Using RECIST 1.1 as the evaluation standard, the independent imaging evaluation
      committee (IRRC) conducted the evaluation. For the first time to evaluate PD, regardless of
      whether they continue to study treatment after progression, the date of the first PD
      evaluated by IRRC will be used for all statistical analysis containing progress information.
    

Intervention name(s): EGFR-TKI; EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin)
Intervention type(s): Drug; Drug
Intervention description(s): (A) Standard programme group, EGFR-TKI targeted therapy;; (B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )
Intervention MeSH terms: Carboplatin; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment