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).
Able to understand and willingness to voluntarily provide written informed consent.
Age 18 to 75 years, males or females.
Histologically confirmed squamous or non-squamous NSCLC.
Ability to provide qualified tumor samples.
Participants with a condition requiring further surgical resection, in the investigator's opinion.
Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC.
Eligible only for incomplete resection.
Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC.
Parallel
SYS6010
DrugSYS6010
Enlonstobart
DrugEnlonstobart
Tislelizumab
Drugadministered via Intravenous (IV) injection
Toripalimab ±+platinum-based doublet chemotherapy
DrugCisplatin; Carboplatin; Pemetrexed; Paclitaxel;
Durvalumab
DrugDurvalumab
Pembrolizumab
DrugPembrolizumab
Nivolumab
DrugNivolumab
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.
Overall Survival (OS)
OS was defined as the time from randomization to the date of death(whatever the cause).
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.
Incidence and severity of Adverse Events (AEs)
EORTC QLQ-30 questionnaire
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