The aim of this single-arm, exploratory clinical study is to evaluate the safety and efficacy of local injection of envafolimab combined with chemotherapy in the first-line treatment of non-small cell lung cancer (NSCLC) patients, and to observe the changes of immune cells in the local immune microenvironment before and after immunotherapy, in order to find new indicators for immunotherapy evaluation.
In this study, 16 patients with NSCLC were enrolled to explore the clinical effect of chemotherapy combined with local injection of Envafolimab. To determine whether the treatment of metastatic/recurrent NSCLC with Envafolimab is effective, and whether the treatment of Envafolimab combined with chemotherapy can prolong the PFS\\OS of patients with NSCLC, and to screen for a more effective treatment mode for Chinese NSCLC patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W.
Northern Jiangsu People's Hospital
Suzhou, Jiangsu, China
RECRUITINGOverall Survival(OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to 2 years
Objective Response Rate(ORR)
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
Time frame: Up to 2 years
Progression free survival(PFS)
Progression free survival (PFS) is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
Time frame: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.
Time frame: Up to 2 years
Duration of response (DOR)
DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Time frame: from first dose to 30 days post the last dose
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