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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513087-26-00

Acronym

SMT112-3003

Enrollment

661

Registered

2024-08-16

Start date

2024-09-10

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Non-small Cell Lung Cancer

Brief summary

Overall Survival (OS), PFS assessed by investigator based on RECIST v1.1

Detailed description

ORR, DCR and DoR assessed by investigator based on RECIST v1.1, Safety assessment: incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results, PK characteristics: ivonescimab serum drug concentrations profiles, Immunogenicity: number and percentage of patients with detectable anti-ivonescimab antibody (ADA) at baseline and post treatment

Interventions

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGCarboplatin 10 mg/ml concentrate for solution for infusion

DRUGPazenir 5 mg/ml powder for dispersion for infusion.

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPaclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGivonescimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS), PFS assessed by investigator based on RECIST v1.1	—

Secondary

Measure	Time frame
ORR, DCR and DoR assessed by investigator based on RECIST v1.1, Safety assessment: incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results, PK characteristics: ivonescimab serum drug concentrations profiles, Immunogenicity: number and percentage of patients with detectable anti-ivonescimab antibody (ADA) at baseline and post treatment	—

Countries

Belgium, France, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026