RECRUITINGPhase 2INTERVENTIONAL
A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. be ≥ 18 years of age on the day of signing of willing to sign a consent form.
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 You should be able to carry out daily activities with 0 level of ability (ECOG 0) to 1.
7. have your organs (liver, kidneys, etc.) are working well enough based on blood tests.
Who Should NOT Join This Trial:
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 previous cancer treatment that works throughout the body (like chemotherapy) 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
DRUG
Pembrolizumab
PD-1 inhibitor
DRUG
Paclitaxel
Chemotherapy
DRUG
Pemetrexed
Chemotherapy
DRUG
Carboplatin
Chemotherapy
Locations (20)
Southern Cancer Care
Daphne, Alabama, United States
Ironwood Cancer and Research Center
Chandler, Arizona, United States
California Cancer Care Associates for Research & Excellence
Fresno, California, United States
California Research Institute
Los Angeles, California, 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
Bioresearch Partner
Hialeah, Florida, 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