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New drug cocktail aims to shrink lung tumors in Late-Stage trial

NCT ID NCT07246863

Disease control Sponsor: CatalYm GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 4 times

Summary

This study tests a new drug called visugromab combined with nivolumab and chemotherapy (docetaxel) in people with advanced non-squamous lung cancer that has worsened after initial treatment. About 131 participants will receive different combinations to see if the new drug helps shrink tumors better than standard chemo alone. The goal is to find a more effective second-line treatment option.

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 131 people

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

Started

Oct 2025

Expected to finish

Oct 2031

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.

Main Inclusion Criteria: * Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC. * Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available targeted agent. * Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment. * Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1. * Participants must have life expectancy of at least 3 months as assessed by the Investigator. * Participants must have ECOG performance status ≤1. Main Exclusion Criteria: * Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC. * Participants must not have a prior malignancy requiring treatment. * Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and/or carcinomatous meningitis * Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.

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Conditions

The condition(s) this trial relates to.

cancer non-small cell lung carcinoma

As listed by the trial registrant

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

Adult solid tumor Metastatic non-squamous non-small cell lung cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    34 sites in 7 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology

    RECRUITING

    Sankt Gallen, CH-9007, Switzerland

  • Clinica Polisano S.R.L

    RECRUITING

    Sibiu, Sibiu County, 55023, Romania

  • Clinics Essen-Mitte

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • Clínica Universidad de Navarra

    RECRUITING

    Madrid, Madrid, 28027, Spain

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift

    RECRUITING

    Bielefeld, North Rhine-Westphalia, 33611, Germany

  • Foundation Bethanien Moers

    RECRUITING

    Moers, North Rhine-Westphalia, 47441, Germany

  • Hospital Clinic of Barcelona

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Hospital Esslingen GmbH

    RECRUITING

    Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

  • Hospital Quiron Dexeus Barcelona

    RECRUITING

    Barcelona, Barcelona, 08028, Spain

  • Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST

    RECRUITING

    Forlì, Emilia-Romagna, 47014, Italy

  • Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department

    RECRUITING

    Ravenna, 48121, Italy

  • MED-Polonia, Sp. z o.o. (LLC)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60693, Poland

  • NYU Langone Hospital - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • NYU Longone Health

    RECRUITING

    New York, New York, 10016, United States

  • National Cancer Institute Regina Elena, IRCCS

    RECRUITING

    Rome, Lazio, 00144, Italy

  • Oncology Reference Center

    RECRUITING

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Regional University Hospital of Malaga

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • SC Oncomed SRL

    RECRUITING

    Timișoara, Timiș County, 300239, Romania

  • START- Rioja

    RECRUITING

    Logroño, La Rioja, 26006, Spain

  • Sf. Nectarie Oncology Center

    RECRUITING

    Craiova, Dolj, 200542, Romania

  • Thorax Clinic Heidelberg

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University Clinic of Navarra - Pamplona

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • University Hospital 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • University Hospital Complex of Santiago (CHUS)

    RECRUITING

    Santiago de Compostela, Galicia, 15706, Spain

  • University Hospital HM Sanchinarro

    RECRUITING

    Madrid, Madrid, 28050, Spain

  • University Hospital Lucus Augusti (HULA)

    RECRUITING

    Lugo, 27003, Spain

  • University Hospital Virgen del Rocio (HUVR)

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • University Hospital of Girona Dr. Josep Trueta

    RECRUITING

    Girona, Girona, 17007, Spain

  • University Hospital of Jaen

    RECRUITING

    Jaén, Andalusia, 23007, Spain

  • University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

    RECRUITING

    Birmingham, Alabama, 35294-3300, United States

More trials for these conditions

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