• Home
  • Study Details
Open

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

The purpose of this research is to measure the safety and effectiveness of ivonescimab compared to pembrolizumab. Ivonescimab is an antibody designed to block proteins that help cancer cells grow and spread, and by blocking these proteins may potentially slow cancer progression.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

The study involves receiving an infusion of either pembrolizumab or ivonescimab every three weeks for up to 2 years. A computer will assign you to receive pembrolizumab or ivonescimab in a process called 'randomization'. Neither you nor the study doctors can choose your group or know which group you are in. Only the pharmacist or nurse who prepare the drug knows which of the two drugs you get. You will meet with a member of the study team in addition to your oncology care team during each of your clinic visits. In addition to normal treatment activities, your blood and urine will be collected for analysis. Between 2 and 11 tablespoons of blood will be collected on treatment cycles 1-7, 9, 11, 13, 15, 17, 19, 21 and at the end of treatment to monitor how your body breaks down the study drug or pembrolizumab, and to see if your body has produced specific antibodies to the study drug or pembrolizumab. You will also be required to fill out 3 questionnaires about your well-being on treatment visits 1-18, and every 3 treatment cycles thereafter.

Incentives

The study drug cost will be covered by the sponsor of the study.

In-person visits:
Up to 50
Phone or online visits:
Up to 16 survival follow-up visits
Total length of participation:
Approximately 4 years which includes a treatment period of up to 24 months followed by 2 years of long-term follow up

Looking for Specific Volunteers

Able to participate:

  • You have been diagnosed with metastatic squamous or non-squamous non-small cell lung cancer
  • You have life expectancy of greater than 3 months
  • You have at least on measurable lesion that is not located in you brain.
  • You have adequate liver, kidney and heart function

Not eligible if:

  • You have received any prior therapy for metastatic non-small cell lung cancer
  • There is evidence of small cell lung cancer in your disease
  • Your cancer cells contain certain gene mutations (EGFR, ALK, ROS1, and BRAF V600E) which have FDA approved therapies
  • Your tumor has invaded or encased a major blood vessel, or you have central nervous system metastases that are causing symptoms
  • You have been diagnosed and treated for a previous cancer within the last 3 years

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Jared Weiss
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lung)

IRB Number

25-0246

ClinicalTrials.gov

NCT06767514

Research for Me logo

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Questions?

  • This email address is being protected from spambots. You need JavaScript enabled to view it.
logo for the North Carolina Translational and Clinical Sciences Institute
logo for UNC Health
logo for UNC School of Medicine
logo for UNC Research