Trial Title:
A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
NCT ID:
NCT06246110
Condition:
NSCLC
Conditions: Official terms:
Paclitaxel
Carboplatin
Pembrolizumab
Pemetrexed
Conditions: Keywords:
Squamous
Nonsquamous
Metastatic
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EIK1001
Description:
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
Arm group label:
Cohort A - Participants with non-squamous NSCLC
Arm group label:
Cohort B - Participants with squamous NSCLC
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
PD-1 inhibitor
Arm group label:
Cohort A - Participants with non-squamous NSCLC
Arm group label:
Cohort B - Participants with squamous NSCLC
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Chemotherapy
Arm group label:
Cohort B - Participants with squamous NSCLC
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Chemotherapy
Arm group label:
Cohort A - Participants with non-squamous NSCLC
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Chemotherapy
Arm group label:
Cohort A - Participants with non-squamous NSCLC
Arm group label:
Cohort B - Participants with squamous NSCLC
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern Cancer Care
Address:
City:
Daphne
Zip:
36608
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amber Malory
Email:
amber.malory@southerncancercenter.com
Facility:
Name:
Ironwood Cancer and Research Center
Address:
City:
Chandler
Zip:
85224
Country:
United States
Status:
Recruiting
Contact:
Last name:
penny Carrel
Email:
Penny.Carrel@ironwoodcrc.org
Facility:
Name:
California Cancer Care Associates for Research & Excellence
Address:
City:
Fresno
Zip:
93720
Country:
United States
Status:
Recruiting
Contact:
Last name:
Helena Tubb
Email:
htubb@ccare.com
Facility:
Name:
California Research Institute
Address:
City:
Los Angeles
Zip:
90027
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nelly Northcross
Email:
nellyrn@caresinst.com
Facility:
Name:
University of Southern California, Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sandy Tran
Email:
Sandy.tran@med.usc.edu
Facility:
Name:
Providence St Joseph Hospital, Center for Cancer Prevention and Treatment
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Lilian Chen
Email:
lillian.chen@stjoe.org
Facility:
Name:
Sutter Health Institute for Medical Research
Address:
City:
Sacramento
Zip:
95816
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Kirsten Babski
Email:
Kirsten.Babski@sutterhealth.org
Facility:
Name:
Rocky Mountain Cancer
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Harsh
Email:
heather.harsh@usoncology.com
Facility:
Name:
Memorial Cancer Institute
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Christina Spencer
Email:
cspencer@ccare.com
Facility:
Name:
Mid-Florida Hematology and Oncology Center
Address:
City:
Orange
Zip:
32763
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Kiran Penta
Email:
kiran@aorcorp.com
Facility:
Name:
Orlando Health Cancer Institute
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Stacy Shankleton
Email:
Stacy.Shankleton@orlandohealth.com
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vonny Ortega
Email:
vonny.ortega@moffitt.org
Facility:
Name:
Kaiser Permanente Hawaii
Address:
City:
Honolulu
Zip:
96819
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shelley Clark, RN, BSN, MS
Phone:
808-432-5555
Phone ext:
1584
Email:
shelley.a.clark@kp.org
Facility:
Name:
Illinois Cancer Specialists
Address:
City:
Niles
Zip:
60714
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisbeth Lyn
Email:
lisbeth.lyn@usoncology.com
Facility:
Name:
Indiana University Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina Nelson
Email:
cmnelson@iu.edu
Facility:
Name:
Health Midwest Oncology Associates of Kansas
Address:
City:
Overland Park
Zip:
66211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katherin Burnside
Email:
katherine.burnside@hcamidwest.com
Facility:
Name:
Cancer Center of Kansas
Address:
City:
Wichita
Zip:
67214
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Meier
Email:
James.Meier@cancercenterofkansas.com
Facility:
Name:
Medstar Franklin Square Cancer Center at Loch Raven Campus
Address:
City:
Baltimore
Zip:
21237
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Avergas
Phone:
443-777-7000
Email:
amy.m.avergas@medstar.net
Facility:
Name:
Maryland Oncology
Address:
City:
Columbia
Zip:
20144
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karla Childers, RN
Email:
karla.childers@usoncology.com
Facility:
Name:
Jersey Shore University Medical Center/Meridian Hematology & Oncology
Address:
City:
Neptune
Zip:
07753
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Laura Micalizzi
Email:
Tracy.Micalizzi@hmhn.org
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
Babylon
Zip:
11702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Diana Molina, RN
Email:
dmolina@nycancer.com
Facility:
Name:
Albert Einstein College of Medicine, Jacobi Medical Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cidney Schulz, RN
Phone:
718-918-6212
Email:
Cidney.Schultz@nychhc.org
Facility:
Name:
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Chau
Email:
ashley.chua@nyulangone.org
Facility:
Name:
Weil Cornell Medical Center
Address:
City:
New York
Zip:
10022
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Alexandra Mavracick
Email:
alm2074@med.cornell.edu
Facility:
Name:
Cancer and Blood Specialists of New York, White Plains Hospital
Address:
City:
White Plains
Zip:
10601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katarzyna Zarychta
Phone:
914-681-0600
Email:
kzarychta@wphospital.org
Facility:
Name:
Willamette Valley
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carmen Angel
Email:
carmen.angel1@usoncology.com
Facility:
Name:
Baptist Cancer Center
Address:
City:
Memphis
Zip:
38120
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Goudy, RN
Email:
jennifer.goudy@bmhcc.org
Facility:
Name:
Texas Oncology, Austin
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shelley Maxfield
Email:
shelley.maxfield@usoncology.com
Facility:
Name:
Texas Oncology, Bedford
Address:
City:
Bedford
Zip:
76022
Country:
United States
Status:
Recruiting
Contact:
Last name:
Deborah Jimerson
Email:
debora.jimerson@usoncology.com
Facility:
Name:
The Center for Cancer and Blood Disorders
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daphne Lindsey
Email:
dlindsey@txcc.com
Facility:
Name:
Blue Ridge Cancer Care Oncology Associates SW VA
Address:
City:
Blacksburg
Zip:
24060
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrea Pollard
Phone:
540-381-0591
Email:
andi.pollard@usoncology.com
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monica Cochrane
Email:
Monica.Cochrane@usoncology.com
Facility:
Name:
Shenandoah Oncology
Address:
City:
Winchester
Zip:
22601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amanda Thompson
Email:
amanda.thompson@usoncology.com
Start date:
February 6, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Eikon Therapeutics
Agency class:
Industry
Source:
Eikon Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06246110
