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Clinical Trial 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 )

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04552613
Study type Interventional
Source The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Status Completed
Phase N/A
Start date November 23, 2020
Completion date September 24, 2023

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