A Randomized, Double-Blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer in Patients Whose Tumors Demonstrate High Pd-L1 Expression (HARMONi-7)
Study of Investigational Medication for Metastatic Lung Cancer
Julian Marin Acevedo
Primary Investigator
Brief description of study
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
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Detailed description of study
Primary Objectives:
* To compare overall survival (OS) between ivonescimab versus pembrolizumab * To compare progression-free survival (PFS) assessed by the Independent Radiology Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 between ivonescimab and pembrolizumab
Secondary Objectives:
* To compare the objective response rate (ORR), disease control rate (DCR) and duration of response (DoR) between ivonescimab versus pembrolizumab, as assessed by the IRRC, based on RECIST v1.1 * To evaluate the safety and tolerability of ivonescimab and compare to pembrolizumab * To evaluate the pharmacokinetic (PK) profile of ivonescimab * To evaluate the immunogenicity of ivonescimab
- Biological: Ivonescimab Injection
- Biological: Pembrolizumab Injection
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Non-Small Cell Lung Cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
- Age ≥ 18 years old at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- Expected life expectancy ≥ 3 months
- Metastatic (Stage IV) NSCLC
- Histologically or cytologically confirmed squamous or non-squamous NSCLC
- Tumor demonstrates high PD-L1 expression ( TPS>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
- 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 for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
- Has received any prior therapy for NSCLC in the metastatic setting.
- Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
- Known actionable genomic alterations for which first-line approved therapies are indicated
- Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
- Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
- Active autoimmune or lung disease requiring systemic therapy
- Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
- Severe infection within 4 weeks prior to randomization
- Major surgical procedures or serious trauma within 4 weeks prior to randomization
- History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
The purpose of this study is to investigate the use of an investigational medication for treating metastatic non-small cell lung cancer (NSCLC) in patients whose tumors show high levels of a protein called PD-L1. Metastatic NSCLC is a type of lung cancer that has spread to other parts of the body. PD-L1 is a protein that can affect how the body's immune system responds to cancer. This study will compare the investigational medication to another treatment to see which works better in extending life and delaying the progression of cancer.
Participants in the study will receive either the investigational medication or a different treatment. The study will monitor how well the treatments work by checking the size of the cancer using special scans. Participants will also be checked for any side effects from the treatments. The study will collect information on how the body processes the investigational medication and how the immune system responds to it.
- Who can participate: Adults 18 years or older with metastatic non-small cell lung cancer and high PD-L1 expression can participate. Key eligibility includes having a performance status score of 0-1 and no prior treatment for metastatic NSCLC.
- Study details: Participants will receive either the investigational medication or another injection. They will have regular scans to monitor cancer and will report any side effects experienced. No placebo is used in this study.
Interested in the study?
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