A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
1 other identifier
interventional
70
1 country
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2024
Typical duration for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2024
CompletedStudy Start
First participant enrolled
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
November 12, 2025
November 1, 2025
2.8 years
January 30, 2024
November 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with safety event during treatment
Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.
Up to 2 years
Secondary Outcomes (1)
Percentage of participants with objective response rate (ORR) and duration of response (DOR).
Up to 4 years
Other Outcomes (2)
Overall Survival (OS) at Final Follow-Up
Up to 4 years
Progression Free Survival (PFS)
Up to 4 years
Study Arms (2)
Cohort A - Participants with non-squamous NSCLC
EXPERIMENTALParticipants in this arm will receive EIK1001 + Standard of Care (SOC).
Cohort B - Participants with squamous NSCLC
EXPERIMENTALParticipants in this arm will receive EIK1001 + Standard of Care (SOC).
Interventions
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
PD-1 inhibitor
Chemotherapy
Eligibility Criteria
You may qualify if:
- be ≥ 18 years of age on the day of signing of informed consent.
- confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
- have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy).
- have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment.
- have not received prior systemic treatment for advanced/metastatic NSCLC.
- have an ECOG Performance Status of 0 to 1.
- have adequate organ function.
You may not qualify if:
- 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.
- 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.
- 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).
- has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
- 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.
- has an active infection requiring therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Southern Cancer Care
Daphne, Alabama, 36608, United States
Ironwood Cancer and Research Center
Chandler, Arizona, 85224, United States
California Cancer Care Associates for Research & Excellence
Fresno, California, 93720, United States
California Research Institute
Los Angeles, California, 90027, United States
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Providence St Joseph Hospital, Center for Cancer Prevention and Treatment
Orange, California, 92868, United States
Sutter Health Institute for Medical Research
Sacramento, California, 95816, United States
Rocky Mountain Cancer
Lone Tree, Colorado, 80124, United States
Bioresearch Partner
Hialeah, Florida, 33013, United States
Memorial Cancer Institute
Hollywood, Florida, 33021, United States
Mid-Florida Hematology and Oncology Center
Orange, Florida, 32763, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Atlanta Piedmont Hospital
Atlanta, Georgia, 30318, United States
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96819, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Accelacare of Duly
Tinley Park, Illinois, 60487, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Health Midwest Oncology Associates of Kansas
Overland Park, Kansas, 66211, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Medstar Franklin Square Cancer Center at Loch Raven Campus
Baltimore, Maryland, 21237, United States
Maryland Oncology
Columbia, Maryland, 20144, United States
Jersey Shore University Medical Center/Meridian Hematology & Oncology
Neptune City, New Jersey, 07753, United States
New York Cancer and Blood Specialists
Babylon, New York, 11702, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Weil Cornell Medical Center
New York, New York, 10022, United States
Albert Einstein College of Medicine, Jacobi Medical Center
The Bronx, New York, 10461, United States
Cancer and Blood Specialists of New York, White Plains Hospital
White Plains, New York, 10601, United States
Messino Cancer Centers
Asheville, North Carolina, 28806, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Willamette Valley
Eugene, Oregon, 97401, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
Texas Oncology, Austin
Austin, Texas, 78745, United States
Texas Oncology, Bedford
Bedford, Texas, 76022, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Blue Ridge Cancer Care Oncology Associates SW VA
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Shenandoah Oncology
Winchester, Virginia, 22601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Etah Kurland, MD
Eikon Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2024
First Posted
February 7, 2024
Study Start
February 6, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
November 12, 2025
Record last verified: 2025-11