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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. Identifier: NCT05899608
Recruitment Status : Not yet recruiting
First Posted : June 12, 2023
Last Update Posted : June 13, 2023
Information provided by (Responsible Party):
Summit Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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)
Estimated Study Start Date : September 30, 2023
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : December 20, 2027

Resource links provided by the National Library of Medicine

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

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) 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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), BRAF V600E, neurotrophic tyrosine receptor kinase (NTRK) 1/2/3, METex14, RET, or ROS1 genes for which first-line approved therapies are available
  • Has received any prior therapy for NSCLC in the metastatic setting
  • Major blood vessel invasion or encasement by cancer or intratumor cavitation

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 identifier (NCT number): NCT05899608

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Contact: Summit Clinical Trial Information 1-833-256-0522

Sponsors and Collaborators
Summit Therapeutics
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Responsible Party: Summit Therapeutics Identifier: NCT05899608    
Other Study ID Numbers: SMT112-3003
First Posted: June 12, 2023    Key Record Dates
Last Update Posted: June 13, 2023
Last Verified: June 2023

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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
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action