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Clinical Trials in the USA / NCT06246110
Active, not recruiting Phase 2

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

NCT06246110 · tracked via the Priya Life Science USA tracker
Sponsor
Eikon Therapeutics
Phase
Phase 2
Started
2024-02-06
Last updated
2026-05-28

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

EIK1001PembrolizumabPaclitaxelPemetrexedCarboplatin

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

Pembrolizumab: PD-1 inhibitor

Paclitaxel: Chemotherapy

Pemetrexed: Chemotherapy

Carboplatin: Chemotherapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. be ≥ 18 years of age on the day of signing of informed consent. 2. confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care. 3. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy). 4. have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment. 5. have not received prior systemic treatment for advanced/metastatic NSCLC. 6. have an ECOG Performance Status of 0 to 1. 7. have adequate organ function. Exclusion Criteria: 1. does not have predominantly squamous cell or non-squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. 2. is currently participating in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001. 3. prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (\< 3 weeks prior to the first dose). 4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration. 5. has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years. 6. has an active infection requiring therapy.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Southern Cancer Care Daphne Alabama
Ironwood Cancer and Research Center Chandler Arizona
California Cancer Care Associates for Research & Excellence Fresno California
California Research Institute Los Angeles California
University of Southern California, Norris Comprehensive Cancer Center Los Angeles California
Providence St Joseph Hospital, Center for Cancer Prevention and Treatment Orange California
Sutter Health Institute for Medical Research Sacramento California
Rocky Mountain Cancer Lone Tree Colorado
Bioresearch Partner Hialeah Florida
Memorial Cancer Institute Hollywood Florida
Mid-Florida Hematology and Oncology Center Orange Florida
Orlando Health Cancer Institute Orlando Florida
Atlanta Piedmont Hospital Atlanta Georgia
Kaiser Permanente Hawaii Honolulu Hawaii
Illinois Cancer Specialists Niles Illinois
Accelacare of Duly Tinley Park Illinois
Indiana University Cancer Center Indianapolis Indiana
Health Midwest Oncology Associates of Kansas Overland Park Kansas
Cancer Center of Kansas Wichita Kansas
Medstar Franklin Square Cancer Center at Loch Raven Campus Baltimore Maryland
Maryland Oncology Columbia Maryland
Jersey Shore University Medical Center/Meridian Hematology & Oncology Neptune City New Jersey
New York Cancer and Blood Specialists Babylon New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York
Weil Cornell Medical Center New York New York
Albert Einstein College of Medicine, Jacobi Medical Center The Bronx New York
Cancer and Blood Specialists of New York, White Plains Hospital White Plains New York
Messino Cancer Centers Asheville North Carolina
Gabrail Cancer Center Canton Ohio
Willamette Valley Eugene Oregon
Tennessee Cancer Specialists Knoxville Tennessee
Baptist Cancer Center Memphis Tennessee
Texas Oncology, Austin Austin Texas
Texas Oncology, Bedford Bedford Texas
The Center for Cancer and Blood Disorders Fort Worth Texas
Blue Ridge Cancer Care Oncology Associates SW VA Blacksburg Virginia
Virginia Cancer Specialists Fairfax Virginia
Shenandoah Oncology Winchester Virginia
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 NCT06246110 on ClinicalTrials.gov ↗ ← All trials in the USA