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New immune drug STK-012 takes on tough lung cancers

NCT ID NCT05098132

Disease control Sponsor: Synthekine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Updated 5 times

Summary

This study tests a new drug called STK-012, which is designed to boost the immune system's ability to fight cancer. It is being tested alone or with standard treatments (pembrolizumab, pemetrexed, carboplatin) in people with advanced solid tumors, especially those with a type of lung cancer called non-squamous non-small cell lung cancer that has not been treated before. The trial has two phases: first to find the right dose and check safety, then to see if adding STK-012 to standard care improves response rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
STK-012 (an engineered immune protein) combined with pembrolizumab, pemetrexed, and carboplatin
What this could lead to
If successful, this could lead to a new treatment option for people with advanced non-small cell lung cancer that doesn't respond to current immunotherapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe. Side effects from the immune system or chemotherapy are possible.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 364 people

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

Started

Jan 2022

Expected to finish

Jan 2029

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.

Selected Inclusion Criteria: 1. Phase 1: Selected advanced solid tumors 2. Phase 2: * Diagnosis of non-small cell lung cancer (NSCLC). * Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment. * Non-squamous (NSQ) cell histology. * No prior systemic therapy for advanced/metastatic NSQ NSCLC. * Must have a tumor that meets at least one of the following criteria on local testing: * PD-L1 negative (TPS \<1%), OR; * STK11 mutated on tumor tissue or ctDNA * No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy. Selected Exclusion Criteria: 2\. Phase 2: * Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment * Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components). * Received radiotherapy ≤ 7 days of the first dose of study treatment. * Known active central nervous system metastases * Any history of carcinomatous meningitis

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

1ST line NSCLC Advanced solid tumor Non-small cell lung cancer Untreated advanced NSCLC

How to take part

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

  1. The places running it

    38 sites in 4 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

  • Baptist Memorial Hospital Cancer Center

    ACTIVE_NOT_RECRUITING

    Memphis, Tennessee, 38120, United States

  • Beaumont Hospital

    RECRUITING

    Dublin, 09, Ireland

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Beverly Hills Cancer Center

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Caraps Medline, Ltd (JSC VIAN)

    RECRUITING

    Tbilisi, 0159, Georgia

  • Cedars Sinai

    RECRUITING

    Los Angeles, California, 90048, United States

  • Clinica Universidad de Navarra - Pamplona

    RECRUITING

    Pamplona, 31008, Spain

  • Columbia University Irving Medical Center

    ACTIVE_NOT_RECRUITING

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Center

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27710, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Georgetown University

    RECRUITING

    Washington D.C., District of Columbia, 20057, United States

  • HealthPartners Cancer Center at Regions Hospital

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hospital Quirón Barcelona

    RECRUITING

    Barcelona, 08023, Spain

  • Hospital Regional de Málaga

    RECRUITING

    Málaga, 29011, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Institute of Clinical Oncology (ICO)

    RECRUITING

    Tbilisi, 0159, Georgia

  • Israel Georgian Medical Research Clinic Healthycore

    RECRUITING

    Tbilisi, 0159, Georgia

  • LTD High Technology Hospital Medcenter

    RECRUITING

    Batumi, 6000, Georgia

  • MD Anderson

    RECRUITING

    Madrid, 28033, Spain

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan-Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Northwell Health

    RECRUITING

    Lake Success, New York, 11042, United States

  • Northwest Medical Specialties

    ACTIVE_NOT_RECRUITING

    Tacoma, Washington, 98405, United States

  • Oncology Consultants

    RECRUITING

    Houston, Texas, 77303, United States

  • Providence Cancer Institute

    RECRUITING

    Portland, Oregon, 97123, United States

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • Renovatio Clinical

    WITHDRAWN

    El Paso, Texas, 79915, United States

  • Renovatio Clinical

    WITHDRAWN

    The Woodlands, Texas, 77380, United States

  • START Dublin

    RECRUITING

    Dublin, 07, Ireland

  • START Rioja

    RECRUITING

    Logroño, 26006, Spain

  • Sarah Cannon Research Institute - Nashville

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37203, United States

  • St. James Hospital

    RECRUITING

    Dublin, 08, Ireland

  • The James Cancer Hospital and Solove Research Institute

    RECRUITING

    Columbus, Ohio, 43210, United States

  • UC San Diego Moores Cancer Center

    ACTIVE_NOT_RECRUITING

    La Jolla, California, 92093-0698, United States

  • UCLA Hematology/Oncology - Santa Monica

    RECRUITING

    Santa Monica, California, 90404, United States

  • UPMC Hillman Cancer Center

    TERMINATED

    Pittsburgh, Pennsylvania, 15232, United States

  • University Hospital Galway

    RECRUITING

    Galway, H91 YR71, Ireland

  • University Hospitals Cleveland

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85721, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yale New Haven Hospital, Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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