Iparomlimab and Tuvonralimab Combined With 2 or 4 Cycles of Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC

Iparomlimab and Tuvonralimab Combined With 2 or 4 Cycles of Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC

This is a two-arm, randomized, multicenter phase II clinical study to evaluate the efficacy and safety of the Iparomlimab and Tuvonralimab combined with 2 or 4 cycles of chemotherapy as neoadjuvant therapy for resectable stage II-IIIB (N2 only) NSCLC.

Inclusion Criteria:

• Histologically or cytologically confirmed, treatment-naïve Stage II-IIIB (N2 only) non-small cell lung cancer (NSCLC) according to the 9th edition of the American Joint Committee on Cancer (AJCC). Only patients judged as T4 based on tumor size are allowed to be enrolled; other T4 conditions (e.g., invasion of the diaphragm, mediastinal involvement) are not permitted.
• MDT assessment (including a thoracic surgeon) confirms resectability.
• Provision of tumor tissue for biomarker analysis (e.g., PD-L1 testing, gene sequencing).
• At least one measurable lesion per RECIST v1.1.
• ECOG performance status 0 or 1.

Exclusion Criteria:

• Confirmed EGFR or ALK mutations.
• Other malignancies within 5 years (exceptions: adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer post-radical surgery, ductal carcinoma in situ post-radical surgery).
• Prior treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors, CTLA-4 inhibitors) or immunostimulatory antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40), or anti-tumor immune cell therapy.
• Use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone equivalent) within 2 weeks prior to enrollment.