Informations générales (source: ClinicalTrials.gov)
A Randomized, Double-blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer (HARMONi-3)
Interventional
Phase 3
Summit Therapeutics (Voir sur ClinicalTrials)
octobre 2023
décembre 2029
02 février 2026
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined
with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line
Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall
survival and progression free survival assessed by investigator. The key secondary
endpoints include response and safety.
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 | 10/11/2025 09:15:04 | Contacter | ||
| CLCC INSTITUT CURIE | 10/04/2025 13:12:07 | Contact (sur clinicalTrials) | |||
Critères
Tous
- Age ≥ 18 years old at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected life expectancy ≥ 3 months
- Metastatic (Stage IV) NSCLC
- Histologically or cytologically confirmed squamous or non-squamous NSCLC
- Recorded measurement of the Tumor Proportion Score (TPS) or Tumor Cells (TC) for
PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization
- 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
- Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for
which first-line approved therapies are available.
- For non-squamous histology patients, actionable driver mutation testing results
are required before randomization.
- Has received any prior therapy for NSCLC in the metastatic setting
- Tumor invasion, encasement of organs (e.g. pericardium, heart, trachea, esophagus,
central bronchi), or major blood vessels (e.g aorta, central veins), if poses a
significant increased risk of bleeding.