Last updated 11 days ago
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
780 patients around the world
Available in United States, Mexico
Summit Therapeutics
780Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
StudyHARMONi-7
SponsorSummit Therapeutics
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06767514
