A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
NCT ID: NCT06246110
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2024-02-06
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A - Participants with non-squamous NSCLC
Participants in this arm will receive EIK1001 + Standard of Care (SOC).
EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
Pembrolizumab
PD-1 inhibitor
Pemetrexed
Chemotherapy
Carboplatin
Chemotherapy
Cohort B - Participants with squamous NSCLC
Participants in this arm will receive EIK1001 + Standard of Care (SOC).
EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
Pembrolizumab
PD-1 inhibitor
Paclitaxel
Chemotherapy
Carboplatin
Chemotherapy
Interventions
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EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
Pembrolizumab
PD-1 inhibitor
Paclitaxel
Chemotherapy
Pemetrexed
Chemotherapy
Carboplatin
Chemotherapy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Eikon Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Etah Kurland, MD
Role: STUDY_DIRECTOR
Eikon Therapeutics
Locations
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Southern Cancer Care
Daphne, Alabama, United States
Ironwood Cancer and Research Center
Chandler, Arizona, United States
California Cancer Care Associates for Research & Excellence
Fresno, California, United States
California Research Institute
Los Angeles, California, United States
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
Providence St Joseph Hospital, Center for Cancer Prevention and Treatment
Orange, California, United States
Sutter Health Institute for Medical Research
Sacramento, California, United States
Rocky Mountain Cancer
Lone Tree, Colorado, United States
Bioresearch Partner
Hialeah, Florida, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Mid-Florida Hematology and Oncology Center
Orange, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Atlanta Piedmont Hospital
Atlanta, Georgia, United States
Kaiser Permanente Hawaii
Honolulu, Hawaii, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Accelacare of Duly
Tinley Park, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Health Midwest Oncology Associates of Kansas
Overland Park, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Medstar Franklin Square Cancer Center at Loch Raven Campus
Baltimore, Maryland, United States
Maryland Oncology
Columbia, Maryland, United States
Jersey Shore University Medical Center/Meridian Hematology & Oncology
Neptune City, New Jersey, United States
New York Cancer and Blood Specialists
Babylon, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Weil Cornell Medical Center
New York, New York, United States
Albert Einstein College of Medicine, Jacobi Medical Center
The Bronx, New York, United States
Cancer and Blood Specialists of New York, White Plains Hospital
White Plains, New York, United States
Messino Cancer Centers
Asheville, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Willamette Valley
Eugene, Oregon, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Texas Oncology, Austin
Austin, Texas, United States
Texas Oncology, Bedford
Bedford, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Blue Ridge Cancer Care Oncology Associates SW VA
Blacksburg, Virginia, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Shenandoah Oncology
Winchester, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Amber Malory
Role: primary
penny Carrel
Role: primary
Helena Tubb
Role: primary
Nelly Northcross
Role: primary
Sandy Tran
Role: primary
Lilian Chen
Role: primary
Kirsten Babski
Role: primary
Heather Harsh
Role: primary
Mabel Cruz
Role: primary
Christina Spencer
Role: primary
Kiran Penta
Role: primary
Stacy Shankleton
Role: primary
Vonny Ortega
Role: primary
Jeff Whorton
Role: primary
Shelley Clark, RN, BSN, MS
Role: primary
Lisbeth Lyn
Role: primary
Karen Sceniak
Role: primary
Christina Nelson
Role: primary
Katherin Burnside
Role: primary
James Meier
Role: primary
Amy Avergas
Role: primary
Karla Childers, RN
Role: primary
Laura Micalizzi
Role: primary
Diana Molina, RN
Role: primary
Ashley Chau
Role: primary
Alexandra Mavracick
Role: primary
Cidney Schulz, RN
Role: primary
Katarzyna Zarychta
Role: primary
Melissa Suttles, RN
Role: primary
Carrie Smith
Role: primary
Carmen Angel
Role: primary
Whitney Henderson
Role: primary
Jennifer Goudy, RN
Role: primary
Shelley Maxfield
Role: primary
Deborah Jimerson
Role: primary
Daphne Lindsey
Role: primary
Andrea Pollard
Role: primary
Monica Cochrane
Role: primary
Amanda Thompson
Role: primary
Other Identifiers
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EIK1001-005
Identifier Type: -
Identifier Source: org_study_id