Actively Recruiting
A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for First-line Treatment of Metastatic Non-small Cell Lung Cancer with High PD-L1 Expression
Led by Summit Therapeutics · Updated on 2026-02-24
780
Participants Needed
202
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ivonescimab as a first-line treatment for patients with metastatic non-small cell lung cancer NSCLC whose tumors have high PD-L1 expression. This study compares ivonescimab against pembrolizumab, another intravenous treatment, to assess overall survival and progression-free survival in these patients. The trial is a randomized, double-blinded, phase 3 study sponsored by Summit Therapeutics. Participants receive either ivonescimab or pembrolizumab as intravenous injections. The study includes two groups one receiving ivonescimab and the other pembrolizumab. Treatment is administered during the study period, and patients are monitored for up to approximately 36 months for survival outcomes and cancer progression. Safety is closely observed through adverse event reporting during and after treatment. Throughout the study, participants undergo evaluations including tumor assessments using RECIST 1.1 criteria and laboratory tests to monitor health and treatment effects. Researchers track objective response rates, disease control, duration of response, and adverse events up to 24 months after treatment. The total study duration allows for comprehensive follow-up to understand treatment impact and safety in this patient population.
CONDITIONS
Brief Title
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected life expectancy of at least 3 months
- Metastatic (Stage IV) non-small cell lung cancer
- Histologically or cytologically confirmed squamous or non-squamous NSCLC
- Tumor with high PD-L1 expression (TPS >50%) based on 22C3 immunohistochemistry assay
- At least one measurable noncerebral lesion according to RECIST 1.1
- No prior systemic treatment for metastatic NSCLC
You will not qualify if you...
- Presence of small cell lung carcinoma
- Prior therapy for metastatic NSCLC
- Enrollment in another interventional clinical study
- Known actionable genomic alterations requiring first-line therapies
- Symptomatic or large CNS metastases, recent CNS radiation, or leptomeningeal disease
- Other prior malignancy unless disease-free for 3 years after curative therapy
- Active autoimmune or lung disease needing systemic therapy
- Pre-existing peripheral neuropathy grade 2 or higher
- Severe infection within 4 weeks before enrollment
- Major surgery or serious trauma within 4 weeks before enrollment
- History of noninfectious pneumonia needing corticosteroids or current interstitial lung disease
Research Team
S
Summit Clinical Trial Information
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