A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer. (TeLuRide-008)

September 1, 2026 updated by: Eikon Therapeutics

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Frenchs Forest, New South Wales, Australia, 2086
        • Recruiting
        • Cancer Care Northern Beaches
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula and Southeast Oncology (PASO) Medical
  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • Instituto Oncologico Dr. Rosell (IOR)
      • Girona, Spain, 17007
        • Recruiting
        • Institut Catala D'Oncologia de Girona
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spain, 11407
        • Recruiting
        • Hospital Universitario de Jerez de la Frontera
    • Castellón
      • Castellon, Castellón, Spain, 12006
        • Recruiting
        • Consorci Hospitalari Provincial de Castello
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Recruiting
        • Southern Cancer Center, P.C.
    • California
      • Glendale, California, United States, 91204
        • Recruiting
        • Los Angeles Cancer Network
      • Orange, California, United States, 92868
        • Recruiting
        • Providence St. Joseph Hospital
    • Colorado
      • Pueblo, Colorado, United States, 81103
        • Recruiting
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Plantation, Florida, United States, 33322
        • Recruiting
        • Florida Clinical Trials Group
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Florida Clinical Trials Group - Tamarac
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF Saint Francis Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico - Comprehensive Cancer Center
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Hospital Long Island
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Hospital Manhattan
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Jacobi Medical Center - Albert Einstein College of Medicine
      • White Plains, New York, United States, 10601
        • Recruiting
        • White Plains Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Recruiting
        • Blue Ridge Cancer Center
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists, PC
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • Shenandoah Oncology P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Arm 1 (Placebo in Combination with SOC)
Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).
Drug: Placebo
Placebo control
Drug: Pembrolizumab (KEYTRUDA®)
PD-1 inhibitor
Drug: Paclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
Drug: Nab-paclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
Drug: Pemetrexed + Cisplatin /Carboplatin
SOC Chemotherapy for non-squamous NSCLC
Experimental: Arm 2 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).
Drug: Pembrolizumab (KEYTRUDA®)
PD-1 inhibitor
Drug: Paclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
Drug: Nab-paclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
Drug: Pemetrexed + Cisplatin /Carboplatin
SOC Chemotherapy for non-squamous NSCLC
Drug: EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
Experimental: Arm 3 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).
Drug: Pembrolizumab (KEYTRUDA®)
PD-1 inhibitor
Drug: Paclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
Drug: Nab-paclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
Drug: Pemetrexed + Cisplatin /Carboplatin
SOC Chemotherapy for non-squamous NSCLC
Drug: EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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
Through study completion, up to 6 years
Overall survival (OS)
Time Frame: 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
Through study completion, up to 10 years
Objective Response (OR)
Time Frame: 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).
Through study completion, up to 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response (OR)
Time Frame: Up to 6 years
Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 by BICR
Up to 6 years
Duration of response (DOR)
Time Frame: Up to 6 years
DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by BICR.
Up to 6 years
Progression-free survival (PFS) by Investigator
Time Frame: 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 Investigator, or death due to any cause, whichever occurs first.
Up to 6 years
Overall Response Rate (ORR) by Investigator
Time Frame: Up to 6 years
Objective Response as defined by participants who demonstrate confirmed CR or PR according to RECIST 1.1 by Investigator.
Up to 6 years
Duration of Response (DOR) by Investigator
Time Frame: Up to 6 years
DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by Investigator.
Up to 6 years
Incidence of Adverse Events (AEs)
Time Frame: Up to 2.5 years
Adverse Events (AEs) and discontinuation of study treatment due to any AE.
Up to 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eikon Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nishitha Reddy, Eikon Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2035

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EIK1001-008
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-525013-23-00 (Ctis)
  • KEYNOTE-G57 (Other Identifier: Merck Sharp & Dohme LLC)
  • MK-3475-G57 (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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