Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
Purpose
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.
Condition
- Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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) 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A - Ivonescimab and chemotherapy |
Subject will receive ivonescimab and chemotherapy |
|
|
Active Comparator Arm B - Pembrolizumab and chemotherapy |
Subject will receive pembrolizumab and chemotherapy |
|
Recruiting Locations
University of Kansas Cancer Center
Westwood 4281639, Kansas 4273857 66205
Westwood 4281639, Kansas 4273857 66205
More Details
- Status
- Recruiting
- Sponsor
- Summit Therapeutics
Detailed Description
The study will enroll approximately 1080 patients randomized in a 1:1 ratio for ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The study will enroll 45-50% of patients with NSCLC squamous histology and 50-55 % of patients with NSCLC non-squamous histology.