Clinical trial NCT05899608: Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Summit Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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) 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. heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: approximately 6 years
measure: Progression Free Survival (PFS)
timeFrame: approximately 3 years
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Clinical Study Site
state: Arizona
city: Little Rock
country: United States
facility: Clinical Study Site
state: Arkansas
city: Cerritos
country: United States
facility: Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: Clinical Study Site
state: California
city: Sacramento
country: United States
facility: Clinical Study Site
state: California
city: Sacramento
country: United States
facility: Clinical Study Site
state: California
city: Santa Monica
country: United States
facility: Clinical Study Site
state: California
city: Santa Rosa
country: United States
facility: Clinical Study Site
state: California
city: Lone Tree
country: United States
facility: Clinical Study Site
state: Colorado
city: Hartford
country: United States
facility: Clinical Study Site
state: Connecticut
city: Fort Myers
country: United States
facility: Clinical Study Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Study Site
state: Florida
city: Ocala
country: United States
facility: Clinical Study Site
state: Florida
city: Palm Bay
country: United States
facility: Clinical Study Site
state: Florida
city: Pembroke Pines
country: United States
facility: Clinical Study Site
state: Florida
city: Pensacola
country: United States
facility: Clinical Study Site
state: Florida
city: Petersburg
country: United States
facility: Clinical Study Site
state: Florida
city: Plantation
country: United States
facility: Clinical Study Site
state: Florida
city: Saint Petersburg
country: United States
facility: Clinical Study Site
state: Florida
city: West Palm Beach
country: United States
facility: Clinical Study Site
state: Florida
city: Peoria
country: United States
facility: Clinical Study Site
state: Illinois
city: Westwood
country: United States
facility: Clinical Study Site
state: Kansas
city: Lexington
country: United States
facility: Clinical Study Site
state: Kentucky
city: Baltimore
country: United States
facility: Clinical Study Site
state: Maryland
city: Burlington
country: United States
facility: Clinical Study Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Clinical Study Site
state: Michigan
city: Detroit
country: United States
facility: Clinical Study Site
state: Michigan
city: Saint Paul
country: United States
facility: Clinical Study Site
state: Minnesota
city: Billings
country: United States
facility: Clinical Study Site
state: Montana
city: New York
country: United States
facility: Clinical Study Site
state: New York
city: New York
country: United States
facility: Clinical Study Site
state: New York
city: Chapel Hill
country: United States
facility: Clinical Study Site
state: North Carolina
city: Charlotte
country: United States
facility: Clinical Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Study Site
state: Ohio
city: Cleveland
country: United States
facility: Clinical Study Site
state: Ohio
city: Cleveland
country: United States
facility: Clinical Study Site
state: Ohio
city: Eugene
country: United States
facility: Clinical Study Site
state: Oregon
city: Charleston
country: United States
facility: Clinical Study Site
state: South Carolina
city: Greenville
country: United States
facility: Clinical Study Site
state: South Carolina
city: Germantown
country: United States
facility: Clinical Study Site
state: Tennessee
city: Nashville
country: United States
facility: Clinical Study Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Clinical Study Site
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Clinical Study Site
state: Texas
city: Tyler
country: United States
facility: Clinical Study Site
state: Texas
city: Norfolk
country: United States
facility: Clinical Study Site
state: Virginia
city: Reston
country: United States
facility: Clinical Study Site
state: Virginia
city: Seattle
country: United States
facility: Clinical Study Site
state: Washington
city: Spokane
country: United States
facility: Clinical Study Site
state: Washington
city: Madison
country: United States
facility: Clinical Study Site
state: Wisconsin
city: London
country: Canada
facility: Clinical Study Site
state: Ontario
city: Ottawa
country: Canada
facility: Clinical Study Site
state: Ontario
city: Regina
country: Canada
facility: Clinical Study Site
state: Saskatchewan
city: Beijing
country: China
facility: Clinical Study Site
city: Beijing
country: China
facility: Clinical Study Site
city: Beijing
country: China
facility: Clinical Study Site
city: Changsha
country: China
facility: Clinical Study Site
city: Fuzhou
country: China
facility: Clinical Study Site
city: Gansu
country: China
facility: Clinical Study Site
city: Guangxi
country: China
facility: Clinical Study Site
city: Hanzhou
country: China
facility: Clinical Study Site
city: Hanzhou
country: China
facility: Clinical Study Site
city: Harbin
country: China
facility: Clinical Study Site
city: Hebei
country: China
facility: Clinical Study Site
city: Henan
country: China
facility: Clinical Study Site
city: Hengyang
country: China
facility: Clinical Study Site
city: Hubei
country: China
facility: Clinical Study Site
city: Hubei
country: China
facility: Clinical Study Site
city: Jiaxing
country: China
facility: Clinical Study Site
city: Jiyuan
country: China
facility: Clinical Study Site
city: Nanchang
country: China
facility: Clinical Study Site
city: Qingdao
country: China
facility: Clinical Study Site
city: Shanghai
country: China
facility: Clinical Study Site
city: Shanghai
country: China
facility: Clinical Study Site
city: Shanghai
country: China
facility: Clinical Study Site
city: Shanghai
country: China
facility: Clinical Study Site
city: Taizhou
country: China
facility: Clinical Study Site
city: Yunnan
country: China
facility: Clinical Study Site
city: Brest
country: France
facility: Clinical Study Site
city: Caen
country: France
facility: Clinical Study Site
city: Caen
country: France
facility: Clinical Study Site
city: Créteil
country: France
facility: Clinical Study Site
city: Le Mans
country: France
facility: Clinical Study Site
city: Marseille
country: France
facility: Clinical Study Site
city: Montpellier
country: France
facility: Clinical Study Site
city: Paris
country: France
facility: Clinical Study Site
city: Pierre-Bénite
country: France
facility: Clinical Study Site
city: Quimper
country: France
facility: Clinical Study Site
city: Rennes
country: France
facility: Clinical Study Site
city: Saint-Herblain
country: France
facility: Clinical Study Site
city: Strasbourg
country: France
facility: Clinical Study Site
city: Tours
country: France
facility: Clinical Study Site
city: Villejuif
country: France
facility: Clinical Study Site
city: Esslingen
country: Germany
facility: Clinical Study Site
city: Frankfurt
country: Germany
facility: Clinical Study Site
city: Gauting
country: Germany
facility: Clinical Study Site
city: Giesen
country: Germany
facility: Clinical Study Site
city: Heidelberg
country: Germany
facility: Clinical Study Site
city: Jena
country: Germany
facility: Clinical Study Site
city: Kempten
country: Germany
facility: Clinical Study Site
city: Luebeck
country: Germany
facility: Clinical Study Site
city: Athens
country: Greece
facility: Clinical Study Site
city: Athens
country: Greece
facility: Clinical Study Site
city: Athens
country: Greece
facility: Clinical Study Site
city: Athens
country: Greece
facility: Clinical Study Site
city: Athens
country: Greece
facility: Clinical Study Site
city: Patra
country: Greece
facility: Clinical Study Site
city: Patra
country: Greece
facility: Clinical Study Site
city: Thessaloníki
country: Greece
facility: Clinical Study Site
city: Thessaloníki
country: Greece
facility: Clinical Study Site
city: Dublin
country: Ireland
facility: Clinical Study Site
city: Dublin
country: Ireland
facility: Clinical Study Site
city: Galway
country: Ireland
facility: Clinical Study Site
city: Ancona
country: Italy
facility: Clinical Study Site
city: Aviano
country: Italy
facility: Clinical Study Site
city: Cremona
country: Italy
facility: Clinical Study Site
city: Lucca
country: Italy
facility: Clinical Study Site
city: Monza
country: Italy
facility: Clinical Study Site
city: Pesaro
country: Italy
facility: Clinical Study Site
city: Peschiera Del Garda
country: Italy
facility: Clinical Study Site
city: Verona
country: Italy
facility: Clinical Study Site
city: Aichi
country: Japan
facility: Clinical Study Site
city: Fukuoka
country: Japan
facility: Clinical Study Site
city: Hiroshima
country: Japan
facility: Clinical Study Site
city: Hokkaido
country: Japan
facility: Clinical Study Site
city: Miyagi
country: Japan
facility: Clinical Study Site
city: Okayama
country: Japan
facility: Clinical Study Site
city: Osaka
country: Japan
facility: Clinical Study Site
city: Osaka
country: Japan
facility: Clinical Study Site
city: Shizuoka
country: Japan
facility: Clinical Study Site
city: Tokyo
country: Japan
facility: Clinical Study Site
city: Tokyo
country: Japan
facility: Clinical Study Site
city: Yamaguchi
country: Japan
facility: Clinical Study Site
city: Yokohama
country: Japan
facility: Clinical Study Site
city: Guadalajara
country: Mexico
facility: Clinical Study Site
city: Monterrey
country: Mexico
facility: Clinical Study Site
city: Monterrey
country: Mexico
facility: Clinical Study Site
city: Monterrey
country: Mexico
facility: Clinical Study Site
city: Poznań
country: Poland
facility: Clinical Study Site
city: Łódź
country: Poland
facility: Clinical Study Site
city: Belgrade
country: Serbia
facility: Clinical Study Site
city: Belgrade
country: Serbia
facility: Clinical Study Site
city: Belgrade
country: Serbia
facility: Clinical Study Site
city: Kamenica
country: Serbia
facility: Clinical Study Site
city: Kragujevac
country: Serbia
facility: Clinical Study Site
city: Niš
country: Serbia
facility: Clinical Study Site
city: Badajoz
country: Spain
facility: Clinical Study Site
city: Badalona
country: Spain
facility: Clinical Study Site
city: Barcelona
country: Spain
facility: Clinical Study Site
city: Barcelona
country: Spain
facility: Clinical Study Site
city: Barcelona
country: Spain
facility: Clinical Study Site
city: Barcelona
country: Spain
facility: Clinical Study Site
city: Barcelona
country: Spain
facility: Clinical Study Site
city: Girona
country: Spain
facility: Clinical Study Site
city: Jaén
country: Spain
facility: Clinical Study Site
city: Lugo
country: Spain
facility: Clinical Study Site
city: Madrid
country: Spain
facility: Clinical Study Site
city: Madrid
country: Spain
facility: Clinical Study Site
city: Pamplona
country: Spain
facility: Clinical Study Site
city: Sevilla
country: Spain
facility: Clinical Study Site
city: Valencia
country: Spain
facility: Clinical Study Site
city: Valencia
country: Spain
facility: Summit Therapeutics Research Center
city: Vigo
country: Spain
facility: Clinical Study Site
city: London
country: United Kingdom
facility: Clinical Study Site
city: Manchester
country: United Kingdom
facility: Clinical Study Site
Study officials:
References: