Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 18, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Summit Therapeutics
- Interventions being studied
- Biological: Ivonescimab Injection; Biological: Pembrolizumab Injection
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Clinical Study SiteChandler, Arizona
- Clinical Study SitePhoenix, Arizona
- Clinical Study SiteHot Springs, Arkansas
- Clinical Study SitesJonesboro, Arkansas
- Clinical Study SiteAlameda, California
- Clinical Study SiteAnaheim, California
- Clinical Study SiteBeverly Hills, California
- Clinical Study SiteCerritos, California
- Clinical Study SiteLos Angeles, California
- Clinical Study SiteLos Angeles, California
- Clinical Study SiteOrange, California
- Clinical Study SiteOxnard, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 18, 2026. Always confirm current availability with the study team.