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

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Southern Cancer Care
RECRUITING
Daphne
Arizona
Ironwood Cancer and Research Center
RECRUITING
Chandler
California
California Cancer Care Associates for Research & Excellence
RECRUITING
Fresno
California Research Institute
RECRUITING
Los Angeles
University of Southern California, Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Providence St Joseph Hospital, Center for Cancer Prevention and Treatment
RECRUITING
Orange
Sutter Health Institute for Medical Research
RECRUITING
Sacramento
Colorado
Rocky Mountain Cancer
RECRUITING
Lone Tree
Florida
Bioresearch Partner
RECRUITING
Hialeah
Memorial Cancer Institute
RECRUITING
Hollywood
Mid-Florida Hematology and Oncology Center
RECRUITING
Orange
Orlando Health Cancer Institute
RECRUITING
Orlando
Moffitt Cancer Center
NOT_YET_RECRUITING
Tampa
Georgia
Atlanta Piedmont Hospital
NOT_YET_RECRUITING
Atlanta
Hawaii
Kaiser Permanente Hawaii
RECRUITING
Honolulu
Illinois
Illinois Cancer Specialists
RECRUITING
Niles
Accelacare of Duly
RECRUITING
Tinley Park
Indiana
Indiana University Cancer Center
RECRUITING
Indianapolis
Kansas
Health Midwest Oncology Associates of Kansas
RECRUITING
Overland Park
Cancer Center of Kansas
RECRUITING
Wichita
Maryland
Medstar Franklin Square Cancer Center at Loch Raven Campus
RECRUITING
Baltimore
Maryland Oncology
RECRUITING
Columbia
North Carolina
Messino Cancer Centers
RECRUITING
Asheville
New Jersey
Jersey Shore University Medical Center/Meridian Hematology & Oncology
RECRUITING
Neptune City
New York
New York Cancer and Blood Specialists
RECRUITING
Babylon
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Weil Cornell Medical Center
RECRUITING
New York
Albert Einstein College of Medicine, Jacobi Medical Center
RECRUITING
The Bronx
Cancer and Blood Specialists of New York, White Plains Hospital
RECRUITING
White Plains
Ohio
Gabrail Cancer Center
RECRUITING
Canton
Oregon
Willamette Valley
RECRUITING
Eugene
Tennessee
Tennessee Cancer Specialists
RECRUITING
Knoxville
Baptist Cancer Center
RECRUITING
Memphis
Texas
Texas Oncology, Austin
RECRUITING
Austin
Texas Oncology, Bedford
RECRUITING
Bedford
The Center for Cancer and Blood Disorders
RECRUITING
Fort Worth
Virginia
Blue Ridge Cancer Care Oncology Associates SW VA
RECRUITING
Blacksburg
Virginia Cancer Specialists
RECRUITING
Fairfax
Shenandoah Oncology
RECRUITING
Winchester
Contact Information
Primary
Brage Garofalo, M.A.
garofalob@eikontx.com
(341) 777-0566
Backup
Surya Vangala
vangalas@eikontx.com
(341) 777-0566
Time Frame
Start Date: 2024-02-06
Estimated Completion Date: 2027-12
Participants
Target number of participants: 70
Treatments
Experimental: Cohort A - Participants with non-squamous NSCLC
Participants in this arm will receive EIK1001 + Standard of Care (SOC).
Experimental: Cohort B - Participants with squamous NSCLC
Participants in this arm will receive EIK1001 + Standard of Care (SOC).
Sponsors
Leads: Eikon Therapeutics

This content was sourced from clinicaltrials.gov

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