Actively Recruiting
IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-09-30
170
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 75 years
- Histologically or cytologically confirmed primary non-squamous NSCLC at Stage IB, II, IIIA, or IIIB (N2)
- No prior anti-NSCLC therapy before surgery
- Able to undergo radical lung resection with adequate pulmonary function
- No EGFR mutations or ALK translocation
- At least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function confirmed at screening
You will not qualify if you...
- Presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, mesenchymal tumor, or mixed NSCLC with predominant squamous features
- Tumor invasion of critical surrounding structures causing symptoms or needing medical intervention
- Pancoast tumor
- Malignant tumor nodules in the opposite lung lobe
- Known or suspected brain or other distant metastases
- Use of Chinese herbal or proprietary medicines with anti-tumor effects or immunomodulatory drugs within 2 weeks before first dose
- Need for systemic corticosteroids or immunosuppressive therapy within 7 days before first dose
- History of arterial thromboembolism within 6 months before first dose
- History of serious venous thromboembolism within 3 months before first dose
- History of pneumonitis requiring corticosteroids or significant lung disease
- Active or uncontrolled medical conditions
- History of immunodeficiency disease
- Active autoimmune disease requiring systemic treatment within 2 years before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China, 110000
Actively Recruiting
Research Team
W
wei zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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