This study is an open-label, randomized, multicenter phase II/III clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR atypical mutations. The study comprises two stages: phase II (dose-exploration stage) and phase III (pivotal study stage)
Age ≥18 years at the time of ICF signing.
Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC).
Confirmed EGFR atypical mutation.
No prior systemic therapy for locally advanced or metastatic NSCLC.
Presence of specific genetic alterations for which approved targeted therapies are available.
Recent participation (within 28 days) in another interventional clinical trial.
Major surgery within 28 days prior to study entry or planned during the study period.
Recent use of anti-tumor traditional proprietary medicine or local anti-tumor therapy.
Single group
PLB1004
DrugAndamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
In phase II，Incidence of Treatment-Emergent Adverse Events (TEAEs)
RP3D or recommended phase 3 treatment regimen
In phase II, choose the RP3D per gained safety and efficacy data
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
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
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
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
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