Back to resultsClinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients
Primary Purpose
Non-Small Cell Lung Cancer
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ivonescimab Injection
Pembrolizumab Injection
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility 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), 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A - Ivonescimab and chemotherapy
Arm B - Pembrolizumab and chemotherapy
Arm Description
Subject will receive ivonescimab and chemotherapy
Subject will receive pembrolizumab and chemotherapy
Outcomes
Primary Outcome Measures
Overall Survival (OS)
Overall Survival (OS) in the ITT population
Secondary Outcome Measures
Progression-Free Survival (PFS)
Progression-free survival (PFS) assessed by investigator based on RECIST v1.1
Adverse Event (AE)
incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05899608
Brief Title
Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
December 20, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Summit Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A - Ivonescimab and chemotherapy
Arm Type
Experimental
Arm Description
Subject will receive ivonescimab and chemotherapy
Arm Title
Arm B - Pembrolizumab and chemotherapy
Arm Type
Active Comparator
Arm Description
Subject will receive pembrolizumab and chemotherapy
Intervention Type
Biological
Intervention Name(s)
Ivonescimab Injection
Intervention Description
Subject will receive ivonescimab and chemotherapy as an IV injection
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab Injection
Intervention Description
Subject will receive pembrolizumab and chemotherapy as an IV injection
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival (OS) in the ITT population
Time Frame
approximately 4 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Progression-free survival (PFS) assessed by investigator based on RECIST v1.1
Time Frame
approximately 4 years
Title
Adverse Event (AE)
Description
incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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), 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Summit Clinical Trial Information
Phone
1-833-256-0522
Email
medicalinformation@smmttx.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients
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