NCT06246110

A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC

A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Eikon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.

Detailed description

This is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of EIK1001 in combination with standard of care in participants with both confirmed stage 4 squamous and non-squamous NSCLC who have not received prior systemic therapy for the advanced disease. The study includes dose finding and evaluates adverse events and efficacy.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	EIK1001	EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
DRUG	Pembrolizumab	PD-1 inhibitor
DRUG	Paclitaxel	Chemotherapy
DRUG	Pemetrexed	Chemotherapy
DRUG	Carboplatin	Chemotherapy

Timeline

• Start date: 2024-02-06
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-02-07
• Last updated: 2025-11-12

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study