IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
NCT07122687 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2025-09-30
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.
Conditions
- Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
Interventions
- DRUG
-
Pemetrexed
500 mg/m2 D1 IV Q3W
- DRUG
-
75 mg/m2 D1 IV Q3W
- DRUG
-
IBI363
1.5 mg/kg D1 IV Q3W
- DRUG
-
AUC 5 mg/ml/min D1 IV Q3W
- DRUG
-
200mg D1 IV Q3W
Sponsors & Collaborators
-
Innovent Biologics (Suzhou) Co. Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-26
- Primary Completion
- 2026-11-30
- Completion
- 2030-04-30
Countries
- China
Study Locations
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