This multicenter study evaluates the efficacy and safety of furmonertinib 160mg versus furmonertinib 80mg plus chemotherapy (carboplatin + pemetrexed) as first-line treatment for EGFR-mutated NSCLC patients with brain metastases. It aims to determine which approach is more effective and safer.
Histopathologically confirmed, unresectable, and non-radiocurable newly -diagnosed locally advanced or metastatic lung adenocarcinoma
Confirmed by local laboratory to have one of the following EGFR mutations: -19Del or L858R (single or mixed mutations are allowed)
Treatment-naive for locally advanced (not suitable for surgery/radiotherapy per investigator) or metastatic NSCLC; adjuvant/neoadjuvant therapy completed >6 months before first progression is allowed (≤6 months is considered pretreated)
At least one measurable tumor lesion per RECIST 1.1 (lesions previously treated with radiotherapy are excluded; if only one measurable lesion exists, biopsy is allowed but baseline imaging must be performed ≥14 days after biopsy)
NSCLC with predominantly squamous cell histology, small cell lung cancer, neuroendocrine carcinoma, or other non-adenocarcinoma histologies
Concurrent positive for other driver genes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation); TP53, RB1, and BRAC mutations are excluded
Expected to receive other anti-tumor therapies during the trial
Major surgery (except vascular access or biopsy) within 4 weeks before first dose or planned during the trial
Parallel
Furmonertinib
DrugOral administration, 160mg once daily.
Furmonertinib
DrugOral administration, 80mg once daily
carboplatin
DrugIntravenous infusion, cycle-based (per study protocol).
pemetrexed
DrugIntravenous infusion, cycle-based (per study protocol).
Median Progression-Free Survival (PFS) as assessed by Investigator
The time from the first dose of the study drug to the progression of the disease (Investigator-Assessed) or death for any reason according to investigator.
Objective Response Rate (ORR) as assessed by RECIST 1.1
Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
Disease Control Rate (DCR) as assessed by RECIST 1.1
Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1.
Central Nervous System (CNS) Objective Response Rate (CNS ORR) as assessed by RECIST 1.1
Proportion of subjects whose central nervous system (CNS) tumors (including intracranial parenchymal metastases and asymptomatic meningeal metastases as defined in the inclusion criteria) are assessed as Complete Response (CR) or Partial Response (PR) according to RECIST1.1.
Central Nervous System (CNS) Disease Control Rate (CNS DCR) as assessed by RECIST 1.1
Proportion of subjects whose central nervous system (CNS) tumors (including intracranial parenchymal metastases and asymptomatic meningeal metastases as defined in the inclusion criteria) are assessed as Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to RECIST 1.1.
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