RECRUITING

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

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Conditions

NSCLCSquamousNonsquamousMetastatic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer

Quick Facts

Study Start:2024-02-06
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06246110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. be ≥ 18 years of age on the day of signing of informed consent.
  2. 2. confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care.
  3. 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. 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. 5. have not received prior systemic treatment for advanced/metastatic NSCLC.
  6. 6. have an ECOG Performance Status of 0 to 1.
  7. 7. have adequate organ function.
  1. 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. 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. 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. 4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration.
  5. 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. 6. has an active infection requiring therapy.

Contacts and Locations

Study Contact

Brage Garofalo, M.A.
CONTACT
(341) 777-0566
garofalob@eikontx.com
Surya Vangala
CONTACT
(341) 777-0566
vangalas@eikontx.com

Principal Investigator

Etah Kurland, MD
STUDY_DIRECTOR
Eikon Therapeutics
Wale Akinseli, MD, MPH
STUDY_DIRECTOR
Eikon Therapeutics

Study Locations (Sites)

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
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
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96819
United States
Illinois Cancer Specialists
Niles, Illinois, 60714
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, New Jersey, 07753
United States
New York Cancer and Blood Specialists
Babylon, New York, 11702
United States
Albert Einstein College of Medicine, Jacobi Medical Center
Bronx, New York, 10461
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
Cancer and Blood Specialists of New York, White Plains Hospital
White Plains, New York, 10601
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

Collaborators and Investigators

Sponsor: Eikon Therapeutics

  • Etah Kurland, MD, STUDY_DIRECTOR, Eikon Therapeutics
  • Wale Akinseli, MD, MPH, STUDY_DIRECTOR, Eikon Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-06
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-02-06
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Squamous
  • Nonsquamous
  • Metastatic

Additional Relevant MeSH Terms

  • NSCLC