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Clinical Trials in the USA / NCT07365319
Recruiting Phase 2/3

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

NCT07365319 · tracked via the Priya Life Science USA tracker
Sponsor
Eikon Therapeutics
Phase
Phase 2/3
Started
2026-06-15
Last updated
2026-09-17

Condition(s) studied

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

Investigational drug(s) / intervention(s)

EIK1001Pembrolizumab (KEYTRUDA®)PlaceboPaclitaxel + CarboplatinNab-paclitaxel + CarboplatinPemetrexed + Cisplatin /Carboplatin

EIK1001: EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist

Pembrolizumab (KEYTRUDA®): PD-1 inhibitor

Placebo: Placebo control

Paclitaxel + Carboplatin: SOC Chemotherapy for squamous NSCLC

Nab-paclitaxel + Carboplatin: SOC Chemotherapy for squamous NSCLC

Pemetrexed + Cisplatin /Carboplatin: SOC Chemotherapy for non-squamous NSCLC

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Participant must be ≥ 18 years old at the time of signing the informed consent. 2. Participant has a life expectancy of at least 3 months. 3. Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC. 4. Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country. 5. Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. 6. Participant has not received prior systemic therapy for advanced/metastatic NSCLC. Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible. 7. Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment. 8. Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is \< 3yrs old). Key Exclusion Criteria: 1. has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC. 2. is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo. 3. has had major surgery (\< 3 weeks prior to the first dose of study intervention administration). 4. has received a live-virus vaccination within 30 days of the start of study intervention initiation. 5. has received radiation therapy within 7 days of the first dose of study intervention administration. 6. has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Southern Cancer Center, P.C. Daphne Alabama Recruiting
Los Angeles Cancer Network Glendale California Recruiting
Providence St. Joseph Hospital Orange California Recruiting
Rocky Mountain Cancer Centers, LLP Pueblo Colorado Recruiting
Florida Clinical Trials Group Plantation Florida Recruiting
Florida Clinical Trials Group - Tamarac Tamarac Florida Recruiting
OSF Saint Francis Medical Center Peoria Illinois Recruiting
University of New Mexico - Comprehensive Cancer Center Albuquerque New Mexico Recruiting
NYU Langone Hospital Long Island Mineola New York Recruiting
NYU Langone Hospital Manhattan New York New York Recruiting
Jacobi Medical Center - Albert Einstein College of Medicine The Bronx New York Recruiting
White Plains Hospital White Plains New York Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
Blue Ridge Cancer Center Blacksburg Virginia Recruiting
Virginia Cancer Specialists, PC Fairfax Virginia Recruiting
Shenandoah Oncology P.C. Winchester Virginia Recruiting
Cancer Care Northern Beaches Frenchs Forest New South Wales Recruiting
Calvary Mater Newcastle Hospital Waratah New South Wales Recruiting
Peninsula and Southeast Oncology (PASO) Medical Frankston Victoria Recruiting
Hospital Universitario de Jerez de la Frontera Jerez de la Frontera Cadiz Recruiting
Consorci Hospitalari Provincial de Castello Castellon Castellón Recruiting
Instituto Oncologico Dr. Rosell (IOR) Barcelona Spain Recruiting
Institut Catala D'Oncologia de Girona Girona Spain Recruiting
Hospital Quirónsalud Málaga Málaga Spain Recruiting

More Eikon Therapeutics trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07365319 on ClinicalTrials.gov ↗ ← All trials in the USA