4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy): Iparomlimab and Tuvonralimab 5mg/kg:5mg/kg,q3W Platinum-based doublet chemotherapy:q3w
4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy): Iparomlimab and Tuvonralimab 5mg/kg:5mg/kg,q3W Platinum-based doublet chemotherapy:q3w
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Pathologic Complete Response (pCR) Rate — One week postoperatively Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of viable tumor cells in the resected lung tumor bed and lymph nodes.
Trial sites (2)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
China
The Second Affiliated Hospital of Air Force Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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