At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ivonescimab Injection (biological), Pembrolizumab Injection (biological)
- How long the study runs
- Study runs about 74 months (dates as stated)
- About the drug or intervention
- Ivonescimab Injection — biological: Subject will receive ivonescimab and chemotherapy as an IV injection · Pembrolizumab Injection — biological: Subject will receive pembrolizumab and chemotherapy as an IV injection
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,600
- Started
- 2023-10-26
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase3 - 1,600 participants
- • This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Leeds - Leeds Teaching Hospitals NHS
- • London - St. Bartholomew's hospital
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
More detail
This study consists of two distinct NSCLC histology cohorts: squamous (N=600) and non-squamous (N=1000), approximately 1600 patients in total. Within each cohort, subjects are randomized in a 1:1 ratio into one of two treatment groups, receiving either ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The two histology cohorts will be analyzed independently
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Age ≥ 18 years old at the time of enrollment
- ✓activity scale (ECOG) performance status score of 0 or 1
- ✓Expected life expectancy ≥ 3 months
- ✓that has spread (Stage IV) NSCLC
- ✓confirmed by testing a sample squamous or non-squamous NSCLC
Who cannot take part
- ✗Histologic or cytopathologic evidence of the presence of small cell lung carcinoma
- ✗Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved...
- ✗For non-squamous histology patients, actionable driver mutation testing results are required before randomization.
- ✗Has received any prior therapy for NSCLC in the that has spread setting
See the full criteria
Where Is This Study? (3 UK sites)
Leeds Teaching Hospitals NHS
Leeds LS2 9JT, United Kingdom
St. Bartholomew's hospital
London EC1A 7BE, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom