Non-Small Cell Lung Cancer
Conditions
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.
Interventions
BIOLOGICALIvonescimab Injection
Subject will receive ivonescimab as an IV injection
BIOLOGICALPembrolizumab Injection
Subject will receive Pembrolizumab as an IV injection
Sponsors
Summit Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to approximately 36 months |
| Progression free survival (PFS) | Up to approximately 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | Up to approximately 36 months |
| Disease control rate ( DCR) | Up to approximately 36 months |
| Duration of response (DoR) | Up to approximately 36 months |
| Adverse Events (AE): incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results | [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. |
Countries
Canada, China, France, Germany, Greece, Hungary, Italy, Japan, Mexico, Poland, Portugal, Romania, Serbia, Spain, Turkey (Türkiye), United States
Contacts
CONTACTSummit Clinical Trial Information
Outcome results
None listed