Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1 (HARMONi-7)

Summit Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Biological: Pembrolizumab Injection; Biological: Ivonescimab Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06767514

SMT112-3007

Details and patient eligibility

About

Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.

Enrollment: 780 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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780 participants in 2 patient groups

Arm A - Ivonescimab

Experimental group

Description:

Subject will receive ivonescimab as an IV injection

Treatment:

Biological: Ivonescimab Injection

Arm B - Pembrolizumab

Active Comparator group

Description:

Subject will receive pembrolizumab as an IV injection

Treatment:

Biological: Pembrolizumab Injection