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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGORR(Objective response rate)
the sum ratio of partial response and complete response(determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1)
Time frame: through study completion, an average of 1 year
ORR(Objective response rate, assessed as per investigators)
the sum ratio of partial response and complete response(assessed as per investigators)
Time frame: through study completion, an average of 1 year
DOR(Duration of response)
The time from the partial response and complete response of patient to patient progressive disease or death
Time frame: The time from the date of first documented partial response or complete response to progressive disease or death, an average of 6 months
OS(Overall survival)
The time from the patient first dose to death
Time frame: Through study completion, an average of 1 year
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