IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
Innovent Biologics (Suzhou) Co. Ltd.
170 participants
Aug 26, 2025
INTERVENTIONAL
Conditions
Summary
This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.
Eligibility
Inclusion Criteria9
- Males and Females, age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed primary non-squamous NSCLC:
- Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);
- No administration of any anti-NSCLC therapy in the pre-operative period;
- Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.
- Participants without EGFR mutations or ALK translocation;
- At least 1 measurable lesion per RECISIT v1.1;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- Adequate organ function confirmed at screening period.
Exclusion Criteria13
- Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;
- Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
- Pancoast tumor;
- Malignant tumor nodule in the contralateral lung lobe;
- Participants with known or suspected brain metastases or other distant metastases;
- Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;
- Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;
- History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;
- History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;
- History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging during the screening period;
- Active or uncontrolled diseases or conditions;
- History of immunodeficiency disease;
- Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.
Interventions
500 mg/m2 D1 IV Q3W
75 mg/m2 D1 IV Q3W
1.5 mg/kg D1 IV Q3W
AUC 5 mg/ml/min D1 IV Q3W
200mg D1 IV Q3W
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07122687