> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/clinical-study-of-ivonescimab-for-first-line-treatment-of-ea26dd09-b6a2-4067-b619-397d0bb8caf0 > Record changed: 2026-10-13 # Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients NCT05899608 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) Participants 1,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) Lead sponsor Summit Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) Start date 2023-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) Number of sites 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Short title** Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Dates **Completion date** 2029-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **First posted** 2023-06-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Primary completion date** 2028-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Start date** 2023-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Size and sites **Participants** 1,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Planned participants** 1,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Number of sites** 260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Lead sponsor** Summit Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Identifiers **Registry ID** NCT05899608 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **ClinicalTrials.gov ID** NCT05899608 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 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 ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05899608) ## Related records ### Drugs (2) - [Ivonescimab](https://trialight.com/data/asset/ivonescimab-abc25b61-44c5-4a6f-99eb-c59828f17211.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Summit Therapeutics](https://trialight.com/data/company/summit-therapeutics-90e22a13-4ed3-42cf-b081-43a343878f39.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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