NCT06767514 · Summit Therapeutics
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
(HARMONi-7)
What this study is about
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating how long patients live and time without the disease getting worse.
View original scientific description
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
Interventions
BIOLOGICAL
Ivonescimab Injection
Subject will receive ivonescimab as an IV injection
BIOLOGICAL
Pembrolizumab Injection
Subject will receive Pembrolizumab as an IV injection
Primary outcome measures
Overall Survival (OS)
Time frame: Up to approximately 36 months
Progression free survival (PFS)
Time frame: Up to approximately 36 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 enrolle
Where
- Chandler, Arizona
- Phoenix, Arizona
- Hot Springs, Arkansas
- Cerritos, California
- Glendale, California
- Irvine, California
- Los Angeles, California
- Mountain View, California
- Murrieta, California
- Newport Beach, California
- Roseville, California
- Sacramento, California
And 73 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 24, 2026 · Source of record for eligibility and locations