IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy to Convert Initially Unresectable Stage III Non-Small Cell Lung Cancer To Resectable Disease: a Phase II, Single-Arm Clinical Trial
This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.
• The patient shall sign the informed consent.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Histologically or cytologically confirmed Stage III (per AJCC 9th) squamous or non-squamous non-small-cell lung cancer (NSCLC) deemed unresectable by the investigator.
• Tumours with mixed NSCLC histology must be categorised as either squamous or non-squamous on the basis of the predominant component. Tumours containing both NSCLC and small-cell lung cancer (SCLC) are excluded.
• Unresectable is defined as following: (1) Multistation or confluent metastasis in ipsilateral mediastinal lymph nodes (2)Contralateral or supraclavicular lymph node metastasis (N3) (3)Invasion of critical organs or major blood vessels (4)Extensive invasion of the chest wall and pleura (5)Special anatomical locations (6）Patient intolerance to lobectomy or pneumonectomy.
• At least one measurable lesion per RECIST v1.1.
• Adequate organ function meet the following standards (within 14 days before first dose, any blood components or growth factor drugs is not permitted):
‣ ANC count ≥ 1.5 × 10⁹/L
⁃ Platelet count ≥ 100 × 10⁹/L
⁃ Hemoglobin ≥ 90 g/L
⁃ Serum Cr ≤ 1.5 times of upper limit of normal (ULN) or calculated creatinine clearance (CLcr) ≥ 50 mL/min
⁃ Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in Gilbert's syndrome)
⁃ AST and ALT ≤ 2.5 × ULN
⁃ INR or APPT ≤ 1.5 × ULN
⁃ left ventricular ejection fraction (LVEF) ≥ 50 %
• Contraception and reproductive status:
⁃ Fertile female patients must voluntarily use effective contraception during the study period and for at least 3 months after treatment completion, and urine or serum pregnancy test result within 72 hours prior to enrollment are negative and must not be breastfeeding. Male patients with female partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose of IBI363.