Open
Actively Recruiting
Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients
About
Brief Summary
This is a Phase 3 Randomized, Controlled, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer. The primary endpoint is overall survival and key secondary endpoints include progression free survival. response and safety.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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 NSCLC
- Tumor Proportion Score (TPS) with PD-L1 expression percent
- 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, or non-squamous NSCLC histology.
- Known actionable genomic alterations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 or genes for which first-line approved therapies are available
- Has received any prior therapy for NSCLC in the metastatic setting
- Tumor invasion, encasement of organs (e.g. heart, trachea, esophagus), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
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Study Stats
Protocol No.
24-5028
Category
Lung Cancer
Principal Investigator
Contact
Location
- UCLA Porter Ranch
- UCLA Santa Monica
- UCLA Ventura
- UCLA Westlake Village