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)
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.
|
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.
|
|
|
- Lung Neoplasms Carcinoma Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma Bronchogenic Bronchial Neoplasms
|