To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification.
Name: Glumetinib
Description: the sum ratio of partial response and complete response(determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1)
Measure: ORR(Objective response rate) Time: through study completion, an average of 1 yearDescription: the sum ratio of partial response and complete response(assessed as per investigators)
Measure: ORR(Objective response rate, assessed as per investigators) Time: through study completion, an average of 1 yearDescription: The time from the partial response and complete response of patient to patient progressive disease or death
Measure: DOR(Duration of response) Time: The time from the date of first documented partial response or complete response to progressive disease or death, an average of 6 monthsDescription: The time from the patient first dose to death
Measure: OS(Overall survival) Time: Through study completion, an average of 1 yearAllocation: N/A
Single Group Assignment
There is one SNP
Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification. --- T790M ---
- Prior exposure to MET-directed or third generation EGFR inhibitors therapy Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy - Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product Negative T790M Mutation and Met Amplification Carcinoma, Non-Small-Cell Lung To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification. --- T790M ---
- Prior exposure to MET-directed or third generation EGFR inhibitors therapy Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy - Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product Negative T790M Mutation and Met Amplification Carcinoma, Non-Small-Cell Lung To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification. --- T790M --- --- T790M ---