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

NCT05899608
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
1,600
clinicaltrials.gov
Lead sponsor
Summit Therapeutics
clinicaltrials.gov
Start date
2023-10-26
clinicaltrials.gov
Number of sites
260
clinicaltrials.gov

Summary
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
clinicaltrials.gov
Short title
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
clinicaltrials.gov
Official title
A Randomized, Double-blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer (HARMONi-3)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-12-31
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First posted
2023-06-12
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Registry last updated
2026-08-24
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Primary completion date
2028-12-31
clinicaltrials.gov
Start date
2023-10-26
clinicaltrials.gov

Participants
1,600
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
1,600
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Protocol amendments
7
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Randomisation ratio
1:1
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Number of sites
260
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Registry sponsor category
Industry
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Lead sponsor
Summit Therapeutics
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05899608
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05899608
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Overall Survival (OS)

    Timeframe: approximately 4 years

    Overall Survival (OS) in the ITT population

  2. Progression Free Survival (PFS)

    Timeframe: approximately 3 years

    Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1

  1. Adverse Event (AE)

    Timeframe: 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 anticancer therapy, whichever occurs first, up to 2 years.

    incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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 or non-squamous NSCLC
  • Recorded measurement of the Tumor Proportion Score (TPS) or Tumor Cells (TC) for PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization
  • At least one measurable noncerebral lesion according to RECIST 1.1
  • No prior systemic treatment for metastatic NSCLC

  • Histologic or cytopathologic evidence of the presence of small cell lung carcinoma

  • Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.

    • For non-squamous histology patients, actionable driver mutation testing results are required before randomization.

  • Has received any prior therapy for NSCLC in the metastatic setting

  • Tumor invasion, encasement of organs (e.g. pericardium, heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.

Sources for eligibility
clinicaltrials.gov

  • Banner University Medical CenterPhoenix, United StatesActive, not recruiting
  • TMC HealthcareTucson, United StatesActive, not recruiting
  • Genesis Cancer and Blood InstituteHot Springs, United StatesActive, not recruiting
  • University of ArkansasLittle Rock, United StatesActive, not recruiting
  • LA Cancer NetworkAnaheim, United StatesActive, not recruiting
  • The Oncology Institute of Hope & InnovationCerritos, United StatesActive, not recruiting
  • University of Southern California (USC)Los Angeles, United StatesActive, not recruiting
  • Cedar Sinai Medical CenterLos Angeles, United StatesActive, not recruiting
  • Valkyrie Clinical TrialsLos Angeles, United StatesActive, not recruiting
  • Sutter Institute for Medical ResearchSacramento, United StatesActive, not recruiting
  • UC Davis Medical CenterSacramento, United StatesActive, not recruiting
  • University of California Los Angeles (UCLA)Santa Monica, United StatesActive, not recruiting
  • Providence Medical FoundationSanta Rosa, United StatesActive, not recruiting
  • Kaiser PermanenteVallejo, United StatesActive, not recruiting
  • Rocky Mountain CancerLone Tree, United StatesActive, not recruiting
  • Banner MD Anderson Cancer Center at North Colorado Medical CenterLoveland, United StatesActive, not recruiting
  • Hartford HospitalHartford, United StatesActive, not recruiting
  • Yale UniversityNew Haven, United StatesActive, not recruiting
  • Florida Cancer Specialists & Research Institute (FCS)-EastFort Myers, United StatesActive, not recruiting
  • BioResearch Partner- Hialeah HospitalHialeah, United StatesActive, not recruiting
  • Memorial Healthcare SystemHollywood, United StatesActive, not recruiting
  • Mayo ClinicJacksonville, United StatesActive, not recruiting
  • Cancer Specialists of North FloridaJacksonville, United StatesActive, not recruiting
  • Ocala OncologyOcala, United StatesActive, not recruiting
  • Cancer Care of BrevardPalm Bay, United StatesActive, not recruiting

And 235 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)