Clinical trial NCT06767514: Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
Official title: A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Summit Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 780
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: Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old at the time of enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
* Expected life expectancy ≥ 3 months
* Metastatic (Stage IV) NSCLC
* Histologically or cytologically confirmed squamous or non-squamous NSCLC
* Tumor demonstrates high PD-L1 expression ( TPS\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
* 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 for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
* Has received any prior therapy for NSCLC in the metastatic setting.
* Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
* Known actionable genomic alterations for which first-line approved therapies are indicated
* Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
* Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
* Active autoimmune or lung disease requiring systemic therapy
* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
* Severe infection within 4 weeks prior to randomization
* Major surgical procedures or serious trauma within 4 weeks prior to randomization
* History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 36 months
measure: Progression free survival (PFS)
timeFrame: Up to approximately 36 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to approximately 36 months
measure: Disease control rate ( DCR)
timeFrame: Up to approximately 36 months
measure: Duration of response (DoR)
timeFrame: Up to approximately 36 months
measure: Adverse Events (AE): incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
timeFrame: [Time Frame: 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 approximately 24 months.
Other outcomes:
Locations:
city: Hot Springs
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: Lone Tree
country: United States
facility: Clinical Study Site
state: Colorado
city: Fort Lauderdale
country: United States
facility: Clinical Study Site
state: Florida
city: Fort Myers
country: United States
facility: Clinical Study Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Study Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Study Site
state: Florida
city: Miami
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: Tamarac
country: United States
facility: Clinical Study Site
state: Florida
city: West Palm Beach
country: United States
facility: Clinical Study Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Study Site
state: Georgia
city: Boston
country: United States
facility: Clinical Study Site
state: Massachusetts
city: Saint Paul
country: United States
facility: Clinical Study Site
state: Minnesota
city: Kansas City
country: United States
facility: Clinical Study Site
state: Missouri
city: Mullica Hill
country: United States
facility: Clinical Study Site
state: New Jersey
city: Columbus
country: United States
facility: Clinical Study Site
state: Ohio
city: Eugene
country: United States
facility: Clinical Study Site
state: Oregon
city: Austin
country: United States
facility: Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Clinical Study Site
state: Texas
city: Webster
country: United States
facility: Clinical Study Site
state: Texas
Study officials:
References: