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A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment (HARMONi)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504434-22-00
Acronym
AK112-301
Enrollment
45
Registered
2023-07-24
Start date
2023-10-03
Completion date
Unknown
Last updated
2025-12-16

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

Conditions

Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment

Brief summary

OS in the mITT population, PFS assessed by IRRC based on RECIST v1.1 in the mITT population

Detailed description

ORR (including DoR) assessed by IRRC based on RECIST v1.1 in the mITT Population, Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results, PK characteristics: AK112 serum drug concentration at different time points after AK112 administration, Immunogenicity assessment: number and percentage of patients with detectable anti-AK112 antibody (ADA).

Interventions

DRUGivonescimab
DRUGPemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion
DRUGCarboplatino Accord 10 mg/ml concentrado para solución para perfusión EFG
DRUGPemetrexed Ever Pharma 25 mg/ml concentrado para solución para perfusion.
DRUGALIMTA 500 mg powder for concentrate for solution for infusion
DRUGPemetrexed Sandoz 500 mg Powder for concentrate for solution for infusion
DRUGPemetrexed Accord 1000 mg powder for concentrate for solution for infusion.
DRUGCarboplatino Pharmacia 10 mg/ml concentrado para solución para perfusión EFG
DRUGPemetrexed Pfizer 500 mg powder for concentrate for solution for infusion
DRUGCarboplatino Teva 10 mg/ml Concentrado para solución para perfusión
DRUGPemetrexed Pfizer 100 mg powder for concentrate for solution for infusion
DRUGPlacebo to match AK112 (Ivonescimab) concentrate for solution for infusion. 10 mg/mL
DRUG10 mL vial
DRUGPemetrexed Aurovit 25 mg/ml concentrado para solución para perfusión
DRUGALIMTA 100 mg powder for concentrate for solution for infusion
DRUGPemetrexed Accord 100 mg powder for concentrate for solution for infusion.
DRUGPemetrexed Sandoz 100 mg Powder for concentrate for solution for infusion
DRUGPemetrexed Accord 500 mg powder for concentrate for solution for infusion.
DRUGPemetrexed Pfizer 1
DRUG000 mg powder for concentrate for solution for infusion

Sponsors

Summit Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
OS in the mITT population, PFS assessed by IRRC based on RECIST v1.1 in the mITT population—

Secondary

MeasureTime frame
ORR (including DoR) assessed by IRRC based on RECIST v1.1 in the mITT Population, Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results, PK characteristics: AK112 serum drug concentration at different time points after AK112 administration, Immunogenicity assessment: number and percentage of patients with detectable anti-AK112 antibody (ADA).—

Countries

France, Italy, Spain

Outcome results

None listed

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