EIK1001: EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
Pembrolizumab (KEYTRUDA®): PD-1 inhibitor
Placebo: Placebo control
Paclitaxel + Carboplatin: SOC Chemotherapy for squamous NSCLC
Nab-paclitaxel + Carboplatin: SOC Chemotherapy for squamous NSCLC
Pemetrexed + Cisplatin /Carboplatin: SOC Chemotherapy for non-squamous NSCLC
Study summary
This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
1. Participant must be ≥ 18 years old at the time of signing the informed consent.
2. Participant has a life expectancy of at least 3 months.
3. Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC.
4. Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country.
5. Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
6. Participant has not received prior systemic therapy for advanced/metastatic NSCLC.
Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible.
7. Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
8. Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is \< 3yrs old).
Key Exclusion Criteria:
1. has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
2. is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo.
3. has had major surgery (\< 3 weeks prior to the first dose of study intervention administration).
4. has received a live-virus vaccination within 30 days of the start of study intervention initiation.
5. has received radiation therapy within 7 days of the first dose of study intervention administration.
6. has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.
Primary outcome measure(s)
Progression-free survival (PFS) — Through study completion, up to 6 years Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first
Overall survival (OS) — Through study completion, up to 10 years OS defined as the time from the first dose of study medication to death due to any cause
Objective Response (OR) — Through study completion, up to 6 years Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only).
Trial sites (24)
Facility
City
Region
Status
Southern Cancer Center, P.C.
Daphne
Alabama
Recruiting
Los Angeles Cancer Network
Glendale
California
Recruiting
Providence St. Joseph Hospital
Orange
California
Recruiting
Rocky Mountain Cancer Centers, LLP
Pueblo
Colorado
Recruiting
Florida Clinical Trials Group
Plantation
Florida
Recruiting
Florida Clinical Trials Group - Tamarac
Tamarac
Florida
Recruiting
OSF Saint Francis Medical Center
Peoria
Illinois
Recruiting
University of New Mexico - Comprehensive Cancer Center
Albuquerque
New Mexico
Recruiting
NYU Langone Hospital Long Island
Mineola
New York
Recruiting
NYU Langone Hospital Manhattan
New York
New York
Recruiting
Jacobi Medical Center - Albert Einstein College of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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