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Taking people in SerbiaPhase 3

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
Belgrade, Kragujevac, and Novi Sad, SerbiaSee the 3 sites
Phase
Phase 3

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 Serbia

  • BelgradeBelgrade, SerbiaTaking people
  • KragujevacKragujevac, SerbiaTaking people
  • Novi SadNovi Sad, SerbiaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

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.

ClinicalTrials.gov NCT06767514 · EU CTIS 2024-518629-14-00