Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (HARMONi-3)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Biological: Ivonescimab Injection
* Biological: Pembrolizumab Injection


Participation Criteria
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Eligibility Criteria
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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 Major blood vessel invasion or encasement by cancer or intratumor cavitation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A - Ivonescimab and chemotherapy<br>Subject will receive ivonescimab and chemotherapy | Biological: Ivonescimab Injection<br>* Subject will receive ivonescimab and chemotherapy as an IV injection<br>|
| Active Comparator: Arm B - Pembrolizumab and chemotherapy<br>Subject will receive pembrolizumab and chemotherapy | Biological: Pembrolizumab Injection<br>* Subject will receive pembrolizumab and chemotherapy as an IV injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall Survival (OS) in the ITT population | approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | Progression-free survival (PFS) assessed by investigator based on RECIST v1.1 | approximately 4 years | 
| Adverse Event (AE) | incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results | From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first, up to 2 years |