Comparing Ivonescimab with Pembrolizumab for non-small cell lung cancer
Official title: Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression
- Phase 3
- 2 groups
- Sites in Edmonton, Etobicoke and 2 more cities
- Recruiting
Interventions
- Biological therapy
Ivonescimab Injection
Subject will receive ivonescimab as an IV injection
- Biological therapy
Pembrolizumab Injection
Subject will receive Pembrolizumab as an IV injection
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
Clinical Study Site
Edmonton, Alberta
- Recruiting
Clinical Study Site
Etobicoke, Ontario
- Recruiting
Clinical Study Site
London, Ontario
- Recruiting
Clinical Study Site
Montreal, Quebec
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years old at the time of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- +Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- +Expected life expectancy ≥ 3 months
- +Metastatic (Stage IV) NSCLC
- +Histologically or cytologically confirmed squamous or non-squamous NSCLC
- +Tumor demonstrates high PD-L1 expression ( TPS\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
- +At least one measurable noncerebral lesion according to RECIST 1.1
- +No prior systemic treatment for metastatic NSCLC.
Exclusion
- −Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Has received any prior therapy for NSCLC in the metastatic setting.
- −Concurrent enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in another clinical study, unless patient is enrolled in a non-interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical study or is completing survival follow -up.
- −Known actionable genomic alterations for which first-line approved therapies are indicated
- −Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
- −Active autoimmune or lung disease requiring systemic therapy
- −Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
- −Severe infection within 4 weeks prior to randomization
- −Major surgical procedures or serious trauma within 4 weeks prior to randomization
- −History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
- −Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Ivonescimab Injection.
Registry label: A: Arm A - Ivonescimab
Group B, the comparison group, receives Pembrolizumab Injection.
Registry label: B: Arm B - Pembrolizumab
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 780 people.
The study is currently expected to finish around June 2029.
The main measurement is taken over: Up to approximately 36 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Overall Survival (OS) — measured over Up to approximately 36 months.
Progression free survival (PFS) — measured over Up to approximately 36 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06767514 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Ivonescimab InjectionBiological
Subject will receive ivonescimab as an IV injection
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Pembrolizumab InjectionBiological
Subject will receive Pembrolizumab as an IV injection
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 36 months.
The study as a whole is currently expected to finish around 2029-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 780 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 14 locations, including: Edmonton, Alberta, Canada; Etobicoke, Ontario, Canada; London, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States, and 8 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
Other Sites (11)
Clinical Study Site
Ann Arbor, Michigan, United States
Clinical Study Site
Detroit, Michigan, United States
Clinical Study Sites
Detroit, Michigan, United States
Clinical Study Sites
Duluth, Minnesota, United States
Clinical Study Site
Minneapolis, Minnesota, United States
Clinical Study Site
Saint Paul, Minnesota, United States
Clinical Study Site
New York, New York, United States
Clinical Study Site
Syracuse, New York, United States
Clinical Site
The Bronx, New York, United States
Clinical Study Site
Seattle, Washington, United States
Clinical Study Site
Vancouver, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.