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RECRUITING

NCT07365319

PHASE2/PHASE3

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

Sponsor: Eikon Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2026-06-15

Completion Date

2040-12-31

Last Updated

2026-11-03

Healthy Volunteers

Conditions

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

Interventions

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

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.

Locations (42)

Southern Cancer Center, P.C.

Daphne, Alabama, United States

Los Angeles Cancer Network

Glendale, California, United States

Providence St. Joseph Hospital

Orange, California, United States

Rocky Mountain Cancer Centers, LLP

Pueblo, Colorado, United States

Omnicure Clinical Research

Doral, Florida, United States

Florida Clinical Trials Group

Plantation, Florida, United States

Florida Clinical Trials Group - Tamarac

Tamarac, Florida, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

University of New Mexico - Comprehensive Cancer Center

Albuquerque, New Mexico, United States

NYU Langone Hospital Long Island

Mineola, New York, United States

NYU Langone Hospital Manhattan

New York, New York, United States

Jacobi Medical Center - Albert Einstein College of Medicine

The Bronx, New York, United States

White Plains Hospital

White Plains, New York, United States

Tennessee Oncology

Nashville, Tennessee, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Blue Ridge Cancer Center

Blacksburg, Virginia, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Shenandoah Oncology P.C.

Winchester, Virginia, United States

Cancer Care Northern Beaches

Frenchs Forest, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Peninsula and Southeast Oncology (PASO) Medical

Frankston, Victoria, Australia

Sunshine Hospital - Western Health

Saint Albans, Victoria, Australia

Kepler Universitaetsklinikum

Linz, Austria

Centre Hospitalier Universitaire Brugmann

Brussels, Belgium

Hospital Evangélico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Nucleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Oncoclinicas Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

University Hospital Carl Gustav Carus Dresden

Dresden, Saxony, Germany

Katholische Marienkrankenhaus gGmbH

Hamburg, Germany

Henry Dunant Hospital Center

Athens, Greece

GCPMED Sp. z o.o., Centrum Medyczne iMed24

Krakow, Lesser Poland Voivodeship, Poland

The Medical Oncology Centre of Rosebank

Saxonwold, Gauteng, South Africa

Task Eden

George, Western Cape, South Africa

Yeungnam University College of Medicine

Daegu, Daegu, South Korea

Gachon University - Gil Medical Center

Incheon, Incheon Gwang'Yeogsi, South Korea

Chonnam National University Hwasun Hospital (CNUHH)

Hwasun, Jeollanam-do, South Korea

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Cadiz, Spain

Consorci Hospitalari Provincial de Castello

Castellon, Castellón, Spain

Hospital Regional Universitario de Malaga

Málaga, Malaga, Spain

Instituto Oncologico Dr. Rosell (IOR)

Barcelona, Spain

Institut Catala D'Oncologia de Girona

Girona, Spain

Hospital Quirónsalud Málaga

Málaga, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (42)