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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504989-37-00

Acronym

SMT112-3003

Enrollment

135

Registered

2024-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

Metastatic Squamous Non-small Cell Lung Cancer

Brief summary

Overall Survival (OS)

Detailed description

PFS assessed by investigator based on RECIST v1.1, ORR (including 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

DRUGPaclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGCarboplatin 10 mg/ml concentrate for solution for infusion

DRUGPazenir 5 mg/ml powder for dispersion for infusion

DRUGivonescimab

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

Measure	Time frame
PFS assessed by investigator based on RECIST v1.1, ORR (including 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	—

Measure

Time frame

—

Countries

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

Outcome results

None listed

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