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New antibody combo aims to boost lung cancer treatment response

NCT ID NCT07098988

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 4 times

Summary

This study tests whether adding the experimental drug visugromab to standard chemotherapy and immunotherapy can shrink tumors better than standard treatment alone in people with advanced non-squamous lung cancer that has not been treated before. About 107 adults with newly diagnosed stage IV disease will receive either visugromab or a placebo, combined with the usual drugs. The main goal is to see how many patients have their tumors shrink significantly.

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 107 people

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

Started

Aug 2025

Expected to finish

Mar 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: * Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC. * Demonstrated absence of actionable mutations (e.g., EGFR, ALK, among others) that suggest/require treatment with available targeted agent. * Measurable disease determined by the local site Investigator/radiology by their assessment per RECIST v1.1. * Have not received prior systemic treatment for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease and did not contain any PD 1/PD L1 directed CPI therapy. * Availability of locally determined PD L1 TPS, determined with a test validated for this purpose, from a tumor tissue biopsy obtained after any potential prior systemic treatment for this disease. Participants with PD-L1 TPS ≥ 50% can only be enrolled in case CPI monotherapy is not clinically indicated. * Availability of a tissue/histological biopsy for translational research investigations and Informed Consent Form (ICF) for biopsy release for translational research signed by participant. The biopsy has to be obtained after any potential prior systemic treatment for this disease and be available for shipment. A cytological sample is not accepted. * Age ≥ 18 years on the day of signing the informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Adequate organ function (bone marrow, hepatic, renal function and coagulation). Main Exclusion Criteria: * Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the predominant cell type) or presence of small cell lung cancer elements (ineligibility independent of percentage). * Any acute or chronic major tissue injury that may require maintained GDF 15 function for tissue protection as per Investigator assessment (diagnosed with myocardial infarction, or liver, kidney or other major organ failure, all within \< 3 months prior to planned treatment start). * Major surgery (defined as a surgery which requires general anesthetic and/or involves opening of body cavities), within 4 weeks of the first dose of study drug. * Received potentially curative radiation therapy to the lung that is \> 30 Gy within 6 months prior to the first dose of study drug. * Received or completed any focal radiotherapy for symptoms within 28 days of the first dose of study drug. * Expected to require any other form of antineoplastic therapy while on trial. * Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction. * Known history of prior malignancy with the exception that the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. * 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 with CNS involvement may be enrolled with mandatory regular imaging of the brain under protocol-defined conditions. * Have one of the following cardiovascular risk factors: myocardial infarction in the past 3 months before planned treatment start; uncontrolled heart failure; uncontrolled ventricular arrhythmia; QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex; peri/myocarditis in the past 3 months before planned treatment start; history of ischemic stroke in the past 3 months before planned treatment start. * Any active autoimmune that has required systemic treatment in the past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes. * Has interstitial lung disease or a history of non-infectious pneumonitis that required systemic steroids or current pneumonitis. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.

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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.

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

    42 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

  • "Sf. Nectarie" Oncology Center, Department of Medical Oncology

    RECRUITING

    Craiova, Dolj, 200542, Romania

  • Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology

    RECRUITING

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Clinica Polisano S.R.L.

    RECRUITING

    Sibiu, 550253, Romania

  • Clinics Essen-Mitte

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • 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

  • Fribourg Cantonal Hospital

    RECRUITING

    Fribourg, Canton of Fribourg, 1708, Switzerland

  • Gral Medical S.R.L. - Oncofort Hospital

    RECRUITING

    Piteşti, 110283, Romania

  • Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology

    RECRUITING

    Großhansdorf, Schleswig-Holstein, 22927, Germany

  • Hospital Quiron Dexeus Barcelona

    RECRUITING

    Barcelona, Catalonia, 08028, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Catalonia, 08003, Spain

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

    RECRUITING

    Meldola, Forli, 47014, Italy

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

    RECRUITING

    Ravenna, 48121, Italy

  • MD Anderson International Cancer Center Spain

    RECRUITING

    Madrid, 28033, Spain

  • MED-Polonia, Sp. z o.o. (LLC)

    RECRUITING

    Poznan, 60-693, Poland

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NYU Longone Health

    RECRUITING

    New York, New York, 10016, United States

  • National Cancer Institute Regina Elena, IRCCS

    RECRUITING

    Rome, 00144, Italy

  • National Cancer Institute, IRCCS

    RECRUITING

    Milan, Milan, 20133, Italy

  • Oncology Reference Center

    RECRUITING

    Aviano, 33081, Italy

  • Regional University Hospital of Malaga

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • SC Oncomed SRL, Department of Medical Oncology

    RECRUITING

    Timișoara, +40 () 727 774 974, Romania

  • START- Rioja

    RECRUITING

    Rioja, La Rioja, 26006, Spain

  • Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology

    RECRUITING

    Prabuty, 82-550, Poland

  • 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 - Madrid

    RECRUITING

    Madrid, Madrid, 28027, Spain

  • University Clinic of Navarra - Pamplona

    RECRUITING

    Pamplona, Chartered Community of Navarre, 31008, Spain

  • University Hospital 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • University Hospital Basel

    RECRUITING

    Basel, 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 Marques de Valdecilla (HUMV)

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • University Hospital Virgen Macarena

    RECRUITING

    Seville, Andalusia, 41009, Spain

  • University Hospital Virgen del Rocio (HUVR)

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • University Hospital Würzburg

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • University Hospital of Jaen

    RECRUITING

    Jaén, Andalusia, 23007, Spain

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294-2936, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06519, United States

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