Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Summit Therapeutics (Voir sur ClinicalTrials)
février 2025
juin 2029
02 février 2026
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with
high PD-L1. Evaluating overall survival and progression free survival.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 08/01/2026 14:40:03 | Contacter | ||
Critères
Tous
- 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 Criteria:
- 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