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New hope for stage 4 lung cancer: experimental combo therapy enters global trial

NCT ID NCT07365319

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 10 times

Summary

This study tests whether adding an experimental drug (EIK1001) to standard immunotherapy and chemotherapy helps people with stage 4 non-small cell lung cancer live longer or slow tumor growth. About 750 adults whose cancer has spread will receive either the new combination or a placebo plus standard treatment. The goal is to see if the new drug improves survival and response rates.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 750 people

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

Started

Jun 2026

Expected to finish

Dec 2040

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.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Non small cell lung cancer (squamous or non squamous) Stage 4 NSCLC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Blue Ridge Cancer Center

    RECRUITING

    Blacksburg, Virginia, 24060, United States

  • Calvary Mater Newcastle Hospital

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Cancer Care Northern Beaches

    RECRUITING

    Frenchs Forest, New South Wales, 2086, Australia

  • Consorci Hospitalari Provincial de Castello

    RECRUITING

    Castellon, Castellón, 12006, Spain

  • Florida Clinical Trials Group

    RECRUITING

    Plantation, Florida, 33322, United States

  • Florida Clinical Trials Group - Tamarac

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Hospital Quirónsalud Málaga

    RECRUITING

    Málaga, 29004, Spain

  • Hospital Universitario de Jerez de la Frontera

    RECRUITING

    Jerez de la Frontera, Cadiz, 11407, Spain

  • Institut Catala D'Oncologia de Girona

    RECRUITING

    Girona, 17007, Spain

  • Instituto Oncologico Dr. Rosell (IOR)

    RECRUITING

    Barcelona, 08028, Spain

  • Jacobi Medical Center - Albert Einstein College of Medicine

    RECRUITING

    The Bronx, New York, 10461, United States

  • Los Angeles Cancer Network

    RECRUITING

    Glendale, California, 91204, United States

  • NYU Langone Hospital Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • NYU Langone Hospital Manhattan

    RECRUITING

    New York, New York, 10016, United States

  • OSF Saint Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Peninsula and Southeast Oncology (PASO) Medical

    RECRUITING

    Frankston, Victoria, 3199, Australia

  • Providence St. Joseph Hospital

    RECRUITING

    Orange, California, 92868, United States

  • Rocky Mountain Cancer Centers, LLP

    RECRUITING

    Pueblo, Colorado, 81103, United States

  • Shenandoah Oncology P.C.

    RECRUITING

    Winchester, Virginia, 22601, United States

  • Southern Cancer Center, P.C.

    RECRUITING

    Daphne, Alabama, 36526, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • University of New Mexico - Comprehensive Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • Virginia Cancer Specialists, PC

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • White Plains Hospital

    RECRUITING

    White Plains, New York, 10601, United States

More trials for these conditions

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