Back to search results

Clinical Study of Ivonescimab for Metastatic NSCLC with High PD-L1

This study is looking at ivonescimab for people with metastatic (cancer that has spread) non-small cell lung cancer (NSCLC) who have high levels of a protein called PD-L1. You might be eligible if you are at least 18 years old, have a good performance status (meaning you can do most daily activities), and have a life expectancy of at least 3 months. The study will compare ivonescimab to pembrolizumab, another treatment for NSCLC. Researchers want to see how long people live (Overall Survival) and how long they live without their cancer growing (Progression Free Survival). The study aims to enroll 780 participants.

Study design
This interventional study plans to enroll 780 participants. It is comparing two treatments: ivonescimab injection and pembrolizumab injection.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 36 months to measure overall survival and progression-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06767514

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

Recruiting
PHASE3Ages 18+InterventionalTreatment
Summit Therapeutics
~780 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Ivonescimab InjectionPembrolizumab Injection

At a glance

Recruiting sites
274 of 274 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to approximately 36 months
+1 more outcome measured

Conditions

Non-Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

274 sites across 106 states
Turkey (Türkiye)15
Spain14
France13
California11
Florida11
Italy10
Germany8
Mexico8

Who to contact

Summit Clinical Trial Information
[email protected]
1-833-256-0522
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age ≥ 18 years old at the time of enrollment
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 randomization.
Has received any prior therapy for NSCLC in the metastatic setting.
Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
Known actionable genomic alterations for which first-line approved therapies are indicated
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
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

What this trial measures

  • Overall Survival (OS)Up to approximately 36 months
  • Progression free survival (PFS)Up to approximately 36 months