Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

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

A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC (NCT06246110) is a Phase 2 interventional studying NSCLC, sponsored by Eikon Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against NSCLC and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 70 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused NSCLC subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

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.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06246110), the sponsor (Eikon Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06246110 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06246110?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06246110?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06246110. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06246110. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.