A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
- Conditions
- NSCLC
- Interventions
- Registration Number
- NCT06246110
- Lead Sponsor
- Eikon Therapeutics
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A - Participants with non-squamous NSCLC EIK1001 Participants in this arm will receive EIK1001 + Standard of Care (SOC). Cohort B - Participants with squamous NSCLC EIK1001 Participants in this arm will receive EIK1001 + Standard of Care (SOC). Cohort B - Participants with squamous NSCLC Paclitaxel Participants in this arm will receive EIK1001 + Standard of Care (SOC). Cohort A - Participants with non-squamous NSCLC Carboplatin Participants in this arm will receive EIK1001 + Standard of Care (SOC). Cohort A - Participants with non-squamous NSCLC Pembrolizumab Participants in this arm will receive EIK1001 + Standard of Care (SOC). Cohort A - Participants with non-squamous NSCLC Pemetrexed Participants in this arm will receive EIK1001 + Standard of Care (SOC). Cohort B - Participants with squamous NSCLC Pembrolizumab Participants in this arm will receive EIK1001 + Standard of Care (SOC). Cohort B - Participants with squamous NSCLC Carboplatin Participants in this arm will receive EIK1001 + Standard of Care (SOC).
- Primary Outcome Measures
Name Time Method Percentage of participants with safety event during treatment Up to 2 years Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.
- Secondary Outcome Measures
Name Time Method Percentage of participants with objective response rate (ORR) and duration of response (DOR). Up to 4 years Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) by RECIST 1.1 and DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, as assessed by the investigator.
Related Research Topics
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Trial Locations
- Locations (39)
Bioresearch Partner
🇺🇸Hialeah, Florida, 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
Southern Cancer Care
🇺🇸Daphne, Alabama, United States
California Research Institute
🇺🇸Los Angeles, California, United States
Ironwood Cancer and Research Center
🇺🇸Chandler, Arizona, United States
California Cancer Care Associates for Research & Excellence
🇺🇸Fresno, California, 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, New Jersey, United States
New York Cancer and Blood Specialists
🇺🇸Babylon, New York, United States
Albert Einstein College of Medicine, Jacobi Medical Center
🇺🇸Bronx, 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
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