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Report for Clinical Trial NCT04338243

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open Label, Multicenter Phase Ib / II Study of 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.

NCT04338243 Negative T790M Mutation and Met Amplification
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: Glumetinib

Description: Phase Ib is a dose escalation study, the initial dose of Glumetinib is 300mg, then will be escalated to 400mg,according to the result of Phase Ib, will confirm the RP2D
Type: Drug
Group Labels: 1

Glumetinib+Osimertinib


Primary Outcomes

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 year

Secondary Outcomes

Description: 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 year

Description: 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 months

Description: The time from the patient first dose to death

Measure: OS(Overall survival)

Time: Through study completion, an average of 1 year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

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 ---



HPO Nodes


HPO: