Actively Recruiting
Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
Led by Akeso · Updated on 2026-04-09
536
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.
CONDITIONS
Official Title
Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and follow study procedures
- Aged 18 to 75 years at randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected life expectancy of at least 3 months
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer
- Locally advanced or metastatic non-small cell lung cancer (AJCC 8th edition)
- Previously treated with systemic platinum-based chemotherapy and PD-1/L1 inhibitors
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Adequate organ function
You will not qualify if you...
- Evidence of small cell lung carcinoma
- Other cancers diagnosed within 3 years before randomization
- Known actionable genomic alterations
- Prior immunotherapy other than PD-1/PD-L1 inhibitors
- Previous treatment with docetaxel
- History of severe bleeding or blood clotting problems
- Active autoimmune disease needing systemic therapy within 2 years before randomization
- History of myocarditis, cardiomyopathy, or serious heart rhythm problems
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
W
Wenting Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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