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 2028
05 avril 2025
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 | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:07 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Clinical Study Site - 13915 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 29107 - Quimper - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 37044 - Tours - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 44805 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 67033 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 69495 - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 75000 - Paris - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 94010 - Créteil - France | Contact (sur clinicalTrials) | ||||
| Clinical Study Site - 94800 - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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) 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
- 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) 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
- 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. heart, trachea, esophagus, central
bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant
increased risk of bleeding.