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A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
NCT06246110 · Eikon Therapeutics
In plain English
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Official title
A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
About this study
This is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of EIK1001 in combination with standard of care in participants with both confirmed stage 4 squamous and non-squamous NSCLC who have not received prior systemic therapy for the advanced disease. The study includes dose finding and evaluates adverse events and efficacy.
Eligibility criteria
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.
Study design
Enrollment target: 70 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-06
Estimated completion: 2027-12
Last updated: 2025-11-12
Interventions
Drug: EIK1001Drug: PembrolizumabDrug: PaclitaxelDrug: PemetrexedDrug: Carboplatin
Primary outcomes
- • Percentage of participants with safety event during treatment (Up to 2 years)
Sponsor
Eikon Therapeutics · industry
Contacts & investigators
ContactGenevieve Doster · contact · dosterg@eikontx.com · (341) 777-0566
InvestigatorEtah Kurland, MD · study_director, Eikon Therapeutics
All locations (39)
Southern Cancer CareRecruiting
Daphne, Alabama, United States
Ironwood Cancer and Research CenterRecruiting
Chandler, Arizona, United States
California Cancer Care Associates for Research & ExcellenceRecruiting
Fresno, California, United States
California Research InstituteRecruiting
Los Angeles, California, United States
University of Southern California, Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Providence St Joseph Hospital, Center for Cancer Prevention and TreatmentRecruiting
Orange, California, United States
Sutter Health Institute for Medical ResearchRecruiting
Sacramento, California, United States
Rocky Mountain CancerRecruiting
Lone Tree, Colorado, United States
Bioresearch PartnerRecruiting
Hialeah, Florida, United States
Memorial Cancer InstituteRecruiting
Hollywood, Florida, United States
Mid-Florida Hematology and Oncology CenterRecruiting
Orange, Florida, United States
Orlando Health Cancer InstituteRecruiting
Orlando, Florida, United States
Moffitt Cancer CenterNot Yet Recruiting
Tampa, Florida, United States
Atlanta Piedmont HospitalNot Yet Recruiting
Atlanta, Georgia, United States
Kaiser Permanente HawaiiRecruiting
Honolulu, Hawaii, United States
Illinois Cancer SpecialistsRecruiting
Niles, Illinois, United States
Accelacare of DulyRecruiting
Tinley Park, Illinois, United States
Indiana University Cancer CenterRecruiting
Indianapolis, Indiana, United States
Health Midwest Oncology Associates of KansasRecruiting
Overland Park, Kansas, United States
Cancer Center of KansasRecruiting
Wichita, Kansas, United States
Medstar Franklin Square Cancer Center at Loch Raven CampusRecruiting
Baltimore, Maryland, United States
Maryland OncologyRecruiting
Columbia, Maryland, United States
Jersey Shore University Medical Center/Meridian Hematology & OncologyRecruiting
Neptune City, New Jersey, United States
New York Cancer and Blood SpecialistsRecruiting
Babylon, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
New York, New York, United States
Weil Cornell Medical CenterRecruiting
New York, New York, United States
Albert Einstein College of Medicine, Jacobi Medical CenterRecruiting
The Bronx, New York, United States
Cancer and Blood Specialists of New York, White Plains HospitalRecruiting
White Plains, New York, United States
Messino Cancer CentersRecruiting
Asheville, North Carolina, United States
Gabrail Cancer CenterRecruiting
Canton, Ohio, United States
Willamette ValleyRecruiting
Eugene, Oregon, United States
Tennessee Cancer SpecialistsRecruiting
Knoxville, Tennessee, United States
Baptist Cancer CenterRecruiting
Memphis, Tennessee, United States
Texas Oncology, AustinRecruiting
Austin, Texas, United States
Texas Oncology, BedfordRecruiting
Bedford, Texas, United States
The Center for Cancer and Blood DisordersRecruiting
Fort Worth, Texas, United States
Blue Ridge Cancer Care Oncology Associates SW VARecruiting
Blacksburg, Virginia, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Shenandoah OncologyRecruiting
Winchester, Virginia, United States