A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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.
Study sites (16)
AL
- Southern Cancer Center, P.C. · Daphne, AL 36526More trials in Daphne
CA
- Los Angeles Cancer Network · Glendale, CA 91204More trials in Glendale
- Providence St. Joseph Hospital · Orange, CA 92868More trials in Orange
CO
- Rocky Mountain Cancer Centers, LLP · Pueblo, CO 81103More trials in Pueblo
FL
- Florida Clinical Trials Group · Plantation, FL 33322More trials in Plantation
- Florida Clinical Trials Group - Tamarac · Tamarac, FL 33321More trials in Tamarac
IL
- OSF Saint Francis Medical Center · Peoria, IL 61637More trials in Peoria
NM
- University of New Mexico - Comprehensive Cancer Center · Albuquerque, NM 87102More trials in Albuquerque
NY
- NYU Langone Hospital Long Island · Mineola, NY 11501More trials in Mineola
- NYU Langone Hospital Manhattan · New York, NY 10016More trials in New York
- Jacobi Medical Center - Albert Einstein College of Medicine · The Bronx, NY 10461More trials in The Bronx
- White Plains Hospital · White Plains, NY 10601More trials in White Plains
TN
- Tennessee Oncology · Nashville, TN 37203More trials in Nashville
VA
- Blue Ridge Cancer Center · Blacksburg, VA 24060More trials in Blacksburg
- Virginia Cancer Specialists, PC · Fairfax, VA 22031More trials in Fairfax
- Shenandoah Oncology P.C. · Winchester, VA 22601More trials in Winchester