Testing ivonescimab against pembrolizumab for advanced lung cancer with high PD-L1
Compares ivonescimab with pembrolizumab as first treatment in adults with advanced lung cancer.
Plain-language title generated from the registry record
Registry title: Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
Key facts
- Where
- Budapest XII, Deszk, Gyula, Kecskemét, and Mátraháza, HungarySee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with metastatic non-small cell lung cancer (NSCLC) whose tumor has high PD-L1 and who have had no treatment yet for the spread disease.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Metastatic (Stage IV) squamous or non-squamous NSCLC, confirmed under the microscope, with at least one measurable lesion outside the brain
- Earlier treatment
- No earlier systemic treatment for metastatic NSCLC
- Biomarker or test result
- High PD-L1 in the tumor (TPS>50%), measured with a 22C3 immunohistochemistry test
Main reasons for not taking part
- Small cell lung cancer
- Known gene change that has an approved first-line treatment
- Symptomatic brain or spinal cord (CNS) metastases, or leptomeningeal disease
- Active autoimmune or lung disease needing systemic therapy, or interstitial lung disease
- Another earlier cancer, unless treated with no return of disease for 3 years
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- What was the PD-L1 result of your tumour test?
- Has your cancer spread to the brain?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT06767514, who can take part
Where in Hungary
- Orszagos Koranyi Pulmonologiai IntezetBudapest XII, HungaryTaking people
- Orszagos Onkologiai IntezetBudapest XII, HungaryTaking people
- University Of SzegedDeszk, HungaryTaking people
- Bekes Varmegyei Koezponti KorhazGyula, HungaryTaking people
- Bacs-Kiskun Varmegyei OktatokorhazKecskemét, HungaryTaking people
- Mátrai GyógyintézetMátraháza, HungaryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Summit Therapeutics
- Trial code
- NCT06767514EU 2024-518629-14-00
- Record updated
- 18 September 2026
- Original description
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.Read full original descriptionShow less
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
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
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; Severe infection within 4 weeks prior to randomization; Major surgical procedures or serious trauma within 4 weeks prior to randomization; 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; History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease; Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5.