A multicenter, single-arm, open study to evaluate the safety and efficacy of Serplulimab in combination with bevacizumab and first-line chemotherapy in driver negative non-squamous NSCLC patients with brain metastases
This is a multicenter, single-arm, open study. Thirty patients with stage IV nsqNSCLC with BMs confirmed by histopathology or cytology and reported negative driver genes within three months were enrolled. To evaluate the safety, tolerability and efficacy of Serplulimab combined with bevacizumab and first-line chemotherapy in driver negative nsqNSCLC subjects with brain metastases. Qualified subjects were selected and entered into the study in sequence. The trial was divided into combination chemotherapy period (C1-C4/C6) and maintenance treatment period (C5/C7-C32). In combination chemotherapy period, all subjects were treated with Serplulimab combined with bevacizumab and chemotherapy agents after entering the study, and in maintenance treatment period, Serplulimab combined with bevacizumab and pemetrexed. The efficacy was evaluated every 3 weeks (Q3W), every 2 cycles in combination chemotherapy and every 3 cycles in maintenance treatment. All subjects received treatment until subjects withdrew their informed consent, disease progression, intolerable toxicity, investigator judgment that medication must be discontinued, loss of follow-up, death, or 2 years of use of Serplulimab, whichever occurred first; At the end of treatment, patients were followed up for survival until death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Serplulimab combined with bevacizumab and first-line chemotherapy
Likun Chen
Guangzhou, Guangdong, China
iPFS
The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first,
Time frame: The time from receipt of study treatment to intracranial tumor PD or to death due to any cause,whichever came first, assessed up to 60 months
PFS
The time from receipt of study treatment to PD or to death due to any cause,,whichever came first,
Time frame: The time from receipt of study treatment to PD or to death due to any cause,whichever came first, assessed up to 60 months.
OS
The time interval between enrollment and death from any cause
Time frame: The time interval between enrollment and death from any cause,,whichever came first, assessed up to 60 months.
iORR
The number and percentage of objective response (PR+CR) of intracranial tumor at each time point after treatment
Time frame: The number and percentage of objective response (PR+CR) of intracranial tumor at each time point after treatment, through study completion, an average of 2 year.
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