This study is an open-label, multicenter phase IIclinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib (phase II) in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR PACC mutations or EGFR L861Q mutations.
This a three-stage study consist a Screening Phase (Day -28 to -1), a Treatment Phase (until treatment discontinuation), and a Follow-up Phase (including end of treatment visit (EOT),end of study visit(EOS), safety follow-up and survival follow-up).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
PLB1004 is a capsule in the form of 80mg and 40mg
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
In phase II,Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 3 years
RP3D
In phase II, choose the RP3D per gained safety and efficacy data
Time frame: Up to 3 years
Objective Response Rate (ORR)
To evaluate the Overall Response Rate (ORR) which is defined by investigator as the proportion of subjects with confirmed best overall response of complete response or partial response per RECIST v1.1
Time frame: Up to 3 years
Duration of Response(DOR)
DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes frst
Time frame: up to 3 years
Disease Control Rate(DCR)
The percentage of tumor patients achieving complete remission (CR), partial remission (PR), or stable disease (SD) following treatment, relative to the total number of evaluable subjects
Time frame: up to 3 years
Progression-Free Survival(PFS)
PFS is defined as the time from the date the first dose until the date of objective disease progression or death by cause whichever comes first, based on investigator review according to RECIST v1.1
Time frame: up to 3 years
6-month Progression-Free Survival Rate
The proportion of subjects who did not experience disease progression or death within 6 months after receiving treatment.
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Time frame: up to 3 years
6-month Overall Survival Rate
The proportion of subjects who did not experience death within 6 months after receiving treatment.
Time frame: up to 3 years
Assess the PK characteristics of Andamertinib
Plasma concentration of Andamertinib
Time frame: On cycle1of day 1and cycle3of day1, samples were collected within 2 hours prior to dosing and 4 hours post-dosing,On Day 1of Cycle 2, Cycle 5, Cycle 7, and all subsequent odd-numbered cycles collected within 2hours prior to dosing(each cycle is 21days)