The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).
This is a randomized, open-label, multicenter, Phase III clinical study. Participants with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR) will be enrolled and randomized in a 1:1 ratio to experimental (SYS6010 + Enlonstobart) or control (Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen) group. Random factors include disease stage (Stage II / IIIA vs. Stage IIIB), Pathological type (non-squamous cell carcinoma vs. squamous cell carcinoma), and lymph node status (positive vs. negative).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
570
SYS6010
Enlonstobart
administered via Intravenous (IV) injection
Disease-Free Survival (DFS) assessed by the independent review committee (IRC)
DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by IRC per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event.
Time frame: Up to approximately 60 months
Overall Survival (OS)
OS was defined as the time from randomization to the date of death(whatever the cause).
Time frame: Up to approximately 60 months
DFS assessed by investigators
DFS was defined as the time from randomization to either the date of disease recurrence as assessed by investigators per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event.
Time frame: Up to approximately 60 months
Incidence and severity of Adverse Events (AEs)
Time frame: Approximately 15 months
EORTC QLQ-30 questionnaire
Time frame: Approximately 13 months
Blood concentration of SYS6010 and Enlonstobart
Time frame: Approximately 13 months
Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)
Time frame: Approximately 13 months
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Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;
Durvalumab
Pembrolizumab
Nivolumab