Evaluating EIK1001 with Pembrolizumab and Chemotherapy for Adults with Stage 4 Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a drug called EIK1001 given intravenously alongside pembrolizumab and standard chemotherapy for patients with stage 4 non-small cell lung cancer NSCLC. This study includes participants with either squamous or non-squamous NSCLC who have not had prior systemic therapy for advanced disease. The study is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 23 trial conducted in two phases and analyzed in three parts including dose optimization, dose expansion, and confirmatory testing. Participants are randomly assigned to one of three groups a placebo combined with standard care, or one of two doses of EIK1001 combined with standard care. Standard care chemotherapy varies by cancer type and may include combinations like pemetrexed with carboplatin or cisplatin for non-squamous NSCLC, or carboplatin with paclitaxel or nab-paclitaxel for squamous NSCLC. The study drugs are given intravenously and participants receive these treatments along with pembrolizumab. The trial aims to monitor several outcomes over multiple years. Throughout the study, participants undergo regular assessments to track progression-free survival, overall survival, and response to treatment for up to 6 to 10 years. Investigators also monitor adverse events for safety up to 2.5 years. Participants will have tumor tissue tested for PD-L1 expression and meet other health and eligibility criteria before starting treatment. The study includes close monitoring of disease progression and treatment effects through evaluations and follow-up visits during and after treatment.

A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.