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Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05899608
Recruitment Status : Recruiting
First Posted : June 12, 2023
Last Update Posted : May 6, 2024
Sponsor:
Information provided by (Responsible Party):
Summit Therapeutics

Study Description
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Brief Summary:
This is a Phase 3 Randomized, Controlled, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer. The primary endpoint is overall survival and key secondary endpoints include progression free survival. response and safety.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Biological: Ivonescimab Injection Biological: Pembrolizumab Injection Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (HARMONi-3)
Actual Study Start Date : October 26, 2023
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : December 20, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A - Ivonescimab and chemotherapy
Subject will receive ivonescimab and chemotherapy
 Biological: Ivonescimab Injection
Subject will receive ivonescimab and chemotherapy as an IV injection
Active Comparator: Arm B - Pembrolizumab and chemotherapy
Subject will receive pembrolizumab and chemotherapy
 Biological: Pembrolizumab Injection
Subject will receive pembrolizumab and chemotherapy as an IV injection


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: approximately 4 years ]
    Overall Survival (OS) in the ITT population


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: approximately 4 years ]
    Progression-free survival (PFS) assessed by investigator based on RECIST v1.1

  2. Adverse Event (AE) [ Time Frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first, up to 2 years. ]
    incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old at the time of enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Expected life expectancy ≥ 3 months
  • Metastatic (Stage IV) NSCLC
  • Histologically or cytologically confirmed squamous NSCLC
  • Tumor Proportion Score (TPS) with PD-L1 expression percent
  • 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, or non-squamous NSCLC histology.
  • Known actionable genomic alterations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 or genes for which first-line approved therapies are available
  • Has received any prior therapy for NSCLC in the metastatic setting
  • Tumor invasion, encasement of organs (e.g. heart, trachea, esophagus), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05899608


Contacts
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Contact: Summit Clinical Trial Information 1-833-256-0522 medicalinformation@smmttx.com

Locations
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United States, California
Summit Therapeutics Research Center Recruiting
Los Angeles, California, United States, 90033
Summit Therapeutics Research Center Recruiting
Los Angeles, California, United States, 90067
Summit Therapeutics Research Center Recruiting
Sacramento, California, United States, 95817
United States, Colorado
Summit Therapeutics Research Center Recruiting
Lone Tree, Colorado, United States, 80124
United States, Florida
Summit Therapeutics Research Center Recruiting
Fort Myers, Florida, United States, 33901
Summit Therapeutics Research Center Recruiting
Jacksonville, Florida, United States, 32256
Summit Therapeutics Research Center Recruiting
Ocala, Florida, United States, 34474
Summit Therapeutics Research Center Recruiting
Palm Bay, Florida, United States, 32901
Summit Therapeutics Research Center Recruiting
Pensacola, Florida, United States, 32503
Summit Therapeutics Research Center Recruiting
Plantation, Florida, United States, 33322
Summit Therapeutics Research Center Recruiting
Saint Petersburg, Florida, United States, 33705
Summit Therapeutics Research Center Recruiting
Tallahassee, Florida, United States, 32308
Summit Therapeutics Research Center Recruiting
West Palm Beach, Florida, United States, 33401
United States, Massachusetts
Summit Therapeutics Research Center Recruiting
Burlington, Massachusetts, United States, 01085
United States, Michigan
Summit Therapeutics Research Center Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Summit Therapeutics Research Center Recruiting
Saint Paul, Minnesota, United States, 55101
United States, Montana
Summit Therapeutics Research Center Recruiting
Billings, Montana, United States, 59102
United States, New York
Summit Therapeutics Research Center Recruiting
Albany, New York, United States, 12206
United States, Ohio
Summit Therapeutics Research Center Recruiting
Cincinnati, Ohio, United States, 45242
Summit Therapeutics Research Center Recruiting
Cleveland, Ohio, United States, 44195
United States, Oregon
Summit Therapeutics Research Center Recruiting
Eugene, Oregon, United States, 97401
United States, South Carolina
Summit Therapeutics Research Center Recruiting
Greenville, South Carolina, United States, 29605
United States, Tennessee
Summit Therapeutics Research Center Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Summit Therapeutics Research Center Recruiting
Austin, Texas, United States, 78745
Summit Therapeutics Research Center Recruiting
Dallas, Texas, United States, 75246
Summit Therapeutics Research Center Recruiting
Harlingen, Texas, United States, 78550
Summit Therapeutics Research Center Recruiting
Tyler, Texas, United States, 75702
Summit Therapeutics Research Center Recruiting
Webster, Texas, United States, 77598
United States, Virginia
Summit Therapeutics Research Center Recruiting
Norfolk, Virginia, United States, 23502
Summit Therapeutics Research Center Recruiting
Reston, Virginia, United States, 20190
United States, Washington
Summit Therapeutics Research Center Recruiting
Spokane, Washington, United States, 99202
Canada, Ontario
Summit Therapeutics Research Center Recruiting
London, Ontario, Canada, N6A5W9
Canada, Saskatchewan
Summit Therapeutics Research Center Recruiting
Regina, Saskatchewan, Canada, S4T7T1
Sponsors and Collaborators
Summit Therapeutics
More Information
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Responsible Party: Summit Therapeutics
ClinicalTrials.gov Identifier: NCT05899608    
Other Study ID Numbers: SMT112-3003
First Posted: June 12, 2023    Key Record Dates
Last Update Posted: May 6, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action