The objective of this prospective, single-arm, single-center clinical study is to evaluate the efficacy and safety of envafolimab combined with platinum-containing dual-drug chemotherapy and recombinant human endostatin regimens for treating patients with operable II, IIIA, and IIIB (T3N2) stage NSCLC.
Patients with stage II, IIIA, and IIIB (T3N2) NSCLC that did not previously receive systemic treatment and can be treated with surgery were recruited. After signing the informed consent, eligible subjects who meet the inclusion criteria will receive neoadjuvant therapy comprising envafolimab combined with platinum-containing chemotherapy and recombinant human endostatin, as well as postoperative envafolimab single-agent adjuvant therapy. During the preoperative neoadjuvant therapy period, 3 cycles of envafolimab (300 mg fixed-dose Q3W) with recombinant human endostatin (210 mg, CIV \[continuous intravenous pump injection\], 72 h, Q3W), and platinum-containing dual-drug chemotherapy (Q3W) will be performed, with a dosing cycle performed every 3 weeks. The study drug will be administered on the first day of each cycle. All subjects will undergo preoperative imaging evaluation and surgical indication evaluation at 3-5 weeks after the third cycle of preoperative medication. After completing the first 3 cycles of neoadjuvant therapy, all subjects persistently presenting indications for surgery will undergo radical surgery for NSCLC within 4-6 weeks according to the standards defined by the World Association for the Study of Lung Cancer. The pathological staging will be performed according to the AJCC Cancer Staging Manual (8th edition). Local pathologists will evaluate the surgical margins of all specimens removed during the operation. Tumor tissue samples collected from subjects during the research process will be submitted to the designated central laboratory for pathological remission assessment and translational research. Postoperative envafolimab monotherapy (300 mg, Q3W) will be initiated at 4-6 weeks post-surgery and maintained for 1 year Adverse events (AE) will be monitored throughout the study period, and the severity of AEs will be assessed according to the guidelines listed in the National Cancer Institute (NCI) Commonly Used Terminology Criteria for Adverse Events (CTCAE) version 5.0 or above. Safety follow-ups will be conducted for all patients receiving treatment and those who warrant early discontinuation. All subjects will be followed up for OS until death, withdrawal of informed consent, or the end of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Envafolimab: 300 mg, D1, Q3W, subcutaneously administered
the second Xiangya hospital
Changsha, Hunan, China
MPR rate
Major pathological reaction (MPR), defined as remaining viable tumor cells ≤ 10% at surgical resection of the primary tumor.MPR rate, defined as the proportion of intention-to-treat (ITT) population reaching MPR.
Time frame: 0-36months
the event-free survival (EFS)
Event-free lifetime (EFS), defined as the time from the beginning of group entry to the occurrence of any of the following events
Time frame: 0-36months
the complete pathological remission rate (pCR)
pCR, defined as the absence of any surviving primary tumor cells on surgical removal of the primary tumor.
Time frame: 0-36months
the disease-free survival (DFS)
DFS, defined as the time from enrollment to local or distant recurrence (including the occurrence of new primary NSCLC) or death from any cause, whichever occurs first.
Time frame: 0-36months
the 3-year survival rate and overall survival (OS)
OS, defined as the time from treatment to the death of the subject due to any cause.
Time frame: 0-36months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, AEs, TEAEs, SAEs,irAEs
The incidence and severity of all AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and immune-related AEs (irAEs), and their correlation with study drugs.
Time frame: 0-36months
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