This is a phase II, single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer. The primary endpoints were the rate of NSCLC converting to resectable tumors and the 1-year progression-free survival (PFS) rate.The secondary endpoints included the rates of R0 resection, major pathological response (MPR) and pathological complete response (pCR), overall survival (OS) and PFS. Multi-omics analysis will be performed to identify potential biomarkers for treatment response.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Patients with unresectable NSCLC will receive serplulimab plus chemotherapy as conversion treatment, and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions.
Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGthe rate of NSCLC converting to resectable tumors
the proportion of unresectable NSCLC patients who are converted to being suitable for radical pneumonectomy after 3-4 cycles serplulimab plus chemotherapy
Time frame: up to 16 weeks
the 1-year progression-free survival (PFS) rate
the proportion of patients who are progression-free after pneumonectomy
Time frame: up to one year
the rate of R0 resection
the proportion of R0 resection in patients who receive pneumonectomy
Time frame: immediately after the surgery
Progression-free survival (PFS)
The duration from the date of initial treatment to the date of disease progression or death due to any cause
Time frame: up to five years
Overall survival (OS)
The duration from the date of initial treatment to the date of death due to any cause
Time frame: up to five years
the rate of major pathological response (MPR)
the proportion of patients who achieve MRP among those receiving pneumonectomy
Time frame: up to 16 weeks
the rate of pathological complete response (pCR)
the proportion of patients who achieve pCR among those receiving pneumonectomy
Time frame: up to 16 weeks
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