Non-Small Cell Lung Cancer
Conditions
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.
Detailed description
This study consists of two distinct NSCLC histology cohorts: squamous (N=600) and non-squamous (N=1000), approximately 1600 patients in total. Within each cohort, subjects are randomized in a 1:1 ratio into one of two treatment groups, receiving either ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The two histology cohorts will be analyzed independently
Interventions
BIOLOGICALIvonescimab Injection
Subject will receive ivonescimab and chemotherapy as an IV injection
BIOLOGICALPembrolizumab Injection
Subject will receive pembrolizumab and chemotherapy 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 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) or Tumor Cells (TC) 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. pericardium, heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | approximately 4 years | Overall Survival (OS) in the ITT population |
| Progression Free Survival (PFS) | approximately 3 years | Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event (AE) | 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. | incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results |
Countries
Belgium, Canada, China, France, Germany, Greece, Ireland, Italy, Japan, Mexico, Poland, Serbia, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTSummit Clinical Trial Information
STUDY_DIRECTORIndu Lal
Summit Therapeutics, Inc.
Outcome results
None listed