Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

Recruiting now · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.

Key facts

Study ID

NCT06767514

Run by

Summit Therapeutics

People needed

780

Starts

2025-02-27

Expected to finish

2029-06-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Clinical Study Site — Phoenix, Arizona, United States (enrolling)
• Clinical Study Site — Hot Springs, Arkansas, United States (enrolling)
• Clinical Study Sites — Jonesboro, Arkansas, United States (enrolling)
• Clinical Study Site — Alameda, California, United States (enrolling)
• Clinical Study Site — Anaheim, California, United States (enrolling)
• Clinical Study Site — Beverly Hills, California, United States (enrolling)
• Clinical Study Site — Cerritos, California, United States (enrolling)
• Clinical Study Site — Los Angeles, California, United States (enrolling)
• Clinical Study Site — Los Angeles, California, United States (enrolling)
• Clinical Study Site — Orange, California, United States (enrolling)
• Clinical Study Site — Oxnard, California, United States (enrolling)
• Clinical Study Site — San Diego, California, United States (enrolling)
• Clinical Study Site — Sunnyvale, California, United States (enrolling)
• Clinical Study Site — Torrance, California, United States (enrolling)
• Clinical Study Site — Aurora, Colorado, United States (enrolling)
• Clinical Study Site — Denver, Colorado, United States (enrolling)
• Clinical Study Site — Grand Junction, Colorado, United States (enrolling)
• Clinical Study Site — Lone Tree, Colorado, United States (enrolling)
• Clinical Study Site — Loveland, Colorado, United States (enrolling)
• Clinical Study Sites — Fort Lauderdale, Florida, United States (enrolling)
• Clinical Study Site — Fort Lauderdale, Florida, United States (enrolling)
• Clinical Study Site — Jacksonville, Florida, United States (enrolling)
• Clinical Study Site — Jacksonville Beach, Florida, United States (enrolling)
• Clinical Study Site — North Venice, Florida, United States (enrolling)
• Clinical Study Site — Chandler, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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