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New combo therapy targets tough lung cancer

NCT ID NCT06246110

Disease control Sponsor: Eikon Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called EIK1001 combined with standard treatments (pembrolizumab and chemotherapy) in 70 people with stage 4 non-small cell lung cancer who haven't had prior treatment. The main goal is to check safety and side effects, while also seeing how well the tumors shrink. This is not a cure, but aims to better control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC

Contacts and locations

Locations

  • Accelacare of Duly

    Tinley Park, Illinois, 60487, United States

  • Albert Einstein College of Medicine, Jacobi Medical Center

    The Bronx, New York, 10461, United States

  • Atlanta Piedmont Hospital

    Atlanta, Georgia, 30318, United States

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Bioresearch Partner

    Hialeah, Florida, 33013, United States

  • Blue Ridge Cancer Care Oncology Associates SW VA

    Blacksburg, Virginia, 24060, United States

  • California Cancer Care Associates for Research & Excellence

    Fresno, California, 93720, United States

  • California Research Institute

    Los Angeles, California, 90027, United States

  • Cancer Center of Kansas

    Wichita, Kansas, 67214, United States

  • Cancer and Blood Specialists of New York, White Plains Hospital

    White Plains, New York, 10601, United States

  • Gabrail Cancer Center

    Canton, Ohio, 44718, United States

  • Health Midwest Oncology Associates of Kansas

    Overland Park, Kansas, 66211, United States

  • Illinois Cancer Specialists

    Niles, Illinois, 60714, United States

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224, United States

  • Jersey Shore University Medical Center/Meridian Hematology & Oncology

    Neptune City, New Jersey, 07753, United States

  • Kaiser Permanente Hawaii

    Honolulu, Hawaii, 96819, United States

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • Maryland Oncology

    Columbia, Maryland, 20144, United States

  • Medstar Franklin Square Cancer Center at Loch Raven Campus

    Baltimore, Maryland, 21237, United States

  • Memorial Cancer Institute

    Hollywood, Florida, 33021, United States

  • Messino Cancer Centers

    Asheville, North Carolina, 28806, United States

  • Mid-Florida Hematology and Oncology Center

    Orange, Florida, 32763, United States

  • New York Cancer and Blood Specialists

    Babylon, New York, 11702, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Providence St Joseph Hospital, Center for Cancer Prevention and Treatment

    Orange, California, 92868, United States

  • Rocky Mountain Cancer

    Lone Tree, Colorado, 80124, United States

  • Shenandoah Oncology

    Winchester, Virginia, 22601, United States

  • Southern Cancer Care

    Daphne, Alabama, 36608, United States

  • Sutter Health Institute for Medical Research

    Sacramento, California, 95816, United States

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909, United States

  • Texas Oncology, Austin

    Austin, Texas, 78745, United States

  • Texas Oncology, Bedford

    Bedford, Texas, 76022, United States

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104, United States

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Weil Cornell Medical Center

    New York, New York, 10022, United States

  • Willamette Valley

    Eugene, Oregon, 97401, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.