The study is being conducted to to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)
1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
3. Histologically or cytologically confirmed NSCLC;
4. Diagnosed with stage II-IIIB NSCLC (according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system for lung cancer (8th edition)), without actionable genomic alterations (AGAs); subjects with non-squamous NSCLC must have previous test results confirming negative EGFR and ALK gene alterations, and if no previous EGFR and ALK test results are available, the subjects are required to undergo relevant tests at the study site; for subjects with squamous NSCLC, if the previous EGFR and/or ALK gene status is unknown, corresponding tests are not required before enrollment in this study;
1. Histologically or cytologically confirmed tumor containing components of small cell lung cancer or neuroendocrine carcinoma;
2. Any prior systemic or local anti-tumor therapy for non-small cell lung cancer, including chemotherapy, radiotherapy, or immunotherapy;
3. History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
4. History of adverse events leading to permanent discontinuation of immunotherapy, or history of ≥ Grade 2 immune-related pneumonitis or immune-related myocarditis;
Parallel
HLX43 DOSE 1
DrugHLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 DOSE 2
DrugHLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
Serplulimab
DrugSerplulimab Injection, Recombinant humanized anti PD 1 monoclonal antibody
MPR
The percentage of residual viable tumor cells ≤ 10% in the resected primary lesion after neoadjuvant therapy, regardless of the presence of residual viable tumor cells in the lymph nodes.
PCR
The absence of residual viable tumor cells in both the resected primary lesion and lymph nodes after neoadjuvant therapy.
ORR
Objective response rate (ORR) is the proportion of subjects with the best overall response being CR or PR (assessed by investigator per RECIST v1.1)
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version \[v\] 5.0
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