A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-free survival (PFS) — Through study completion, up to 6 years
Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first - Overall survival (OS) — Through study completion, up to 10 years
OS defined as the time from the first dose of study medication to death due to any cause - Objective Response (OR) — Through study completion, up to 6 years
Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only).
Trial sites (42)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Omnicure Clinical Research | Doral | Florida | 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 |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 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 |
| Sunshine Hospital - Western Health | Saint Albans | Victoria | Recruiting |
| Kepler Universitaetsklinikum | Linz | Austria | Recruiting |
| Centre Hospitalier Universitaire Brugmann | Brussels | Belgium | Recruiting |
| Hospital Evangélico de Cachoeiro de Itapemirim | Cachoeiro de Itapemirim | Espírito Santo | Recruiting |
| Nucleo de Oncologia da Bahia | Salvador | Estado de Bahia | Recruiting |
| Oncoclinicas Rio de Janeiro | Rio de Janeiro | Rio de Janeiro | Recruiting |
| University Hospital Carl Gustav Carus Dresden | Dresden | Saxony | Recruiting |
| Katholische Marienkrankenhaus gGmbH | Hamburg | Germany | Recruiting |
| Henry Dunant Hospital Center | Athens | Greece | Recruiting |
| GCPMED Sp. z o.o., Centrum Medyczne iMed24 | Krakow | Lesser Poland Voivodeship | Recruiting |
| The Medical Oncology Centre of Rosebank | Saxonwold | Gauteng | Recruiting |
| Task Eden | George | Western Cape | Recruiting |
| Yeungnam University College of Medicine | Daegu | Daegu | Recruiting |
| Gachon University - Gil Medical Center | Incheon | Incheon Gwang'Yeogsi | Recruiting |
| Chonnam National University Hwasun Hospital (CNUHH) | Hwasun | Jeollanam-do | Recruiting |
| Hospital Universitario de Jerez de la Frontera | Jerez de la Frontera | Cadiz | Recruiting |
| Consorci Hospitalari Provincial de Castello | Castellon | Castellón | Recruiting |
| Hospital Regional Universitario de Malaga | Málaga | Malaga | Recruiting |
| Instituto Oncologico Dr. Rosell (IOR) | Barcelona | Spain | Recruiting |
+ 2 more sites — see the full list on the official registry below.
More Eikon Therapeutics trials in the USA
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