The primary objective of this study is to evaluate whether neoadjuvant SBRT as an immunomodulator in combination with apalolimab and toripalimab (QL1706) plus chemotherapy improves the pathological complete response (pCR) rate in patients with resectable stage IIA-IIIB LUAD. The secondary objectives include major pathological response (MPR), disease-free survival (DFS), R0 resection rate, the feasibility and safety. Moreover, the potential predictors for pathological response also will be explored.
Voluntarily participates in the study and provides written informed consent;
Aged 18-75 years, with no restriction on sex;
Histologically or cytologically confirmed diagnosis of non-small-cell lung cancer (NSCLC);
Has not received prior systemic therapy and is willing to undergo neoadjuvant treatment for stage cⅡ-Ⅲ (N2a) disease, according to the 9th edition of the AJCC staging system (Appendix 1);
1. Presence of locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the 2019 Multidisciplinary Consensus on Stage III Non-Small-Cell Lung Cancer (NSCLC), including certain stage IIIA and IIIB cases and all stage IIIC cases. Typically, this includes N2 disease with a single mediastinal lymph node ≥3 cm in short axis or multiple fused lymph nodes (≥2 cm in short axis on CT), as well as T4 lesions invading the esophagus, heart, aorta, or pulmonary veins, and all N3 disease.
Single group
apalolimab and toripalimab (QL1706)
DrugQL1706 is a bispecific antibody developed using the MabPair™ biotechnology platform. It comprises two engineered monoclonal antibodies targeting PD-1 and CTLA-4, respectively, in a fixed ratio of approximately 2:1 (65:35 ± 10%).
pCR
MPR
DFS
Safety(AEs)
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