NCT07365319

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

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Eikon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.

Detailed description

This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).

Conditions

• Non Small Cell Lung Cancer (Squamous or Non Squamous)
• Stage 4 NSCLC

Interventions

Type	Name	Description
DRUG	EIK1001	EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
DRUG	Pembrolizumab (KEYTRUDA®)	PD-1 inhibitor
DRUG	Placebo	Placebo control
DRUG	Paclitaxel + Carboplatin	SOC Chemotherapy for squamous NSCLC
DRUG	Nab-paclitaxel + Carboplatin	SOC Chemotherapy for squamous NSCLC
DRUG	Pemetrexed + Cisplatin /Carboplatin	SOC Chemotherapy for non-squamous NSCLC

Timeline

• Start date: 2026-05-18
• Primary completion: 2035-12-31
• Completion: 2040-12-31
• First posted: 2026-01-26
• Last updated: 2026-01-26

Regulatory

• FDA-regulated drug study