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New hope for tough lung cancers: drug combo trial launches

NCT ID NCT05117242

Disease control Sponsor: Genmab 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests a new drug called acasunlimab, either alone or combined with the cancer drug pembrolizumab, in people with advanced non-small cell lung cancer that has come back or stopped responding to standard treatments. About 125 adults will receive the drugs intravenously every 3 or 6 weeks for around 6 months. The goal is to see if the combination shrinks tumors and is safe.

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

125 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Aug 2026

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: * Have signed an informed consent form (ICF) * Be at least 18 years of age. * Have histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 mAb for metastatic disease * Have a tumor PD-L1 expression result available prior to first treatment demonstrating PD-L1 expression in ≥1% of tumor cells as assessed by a central or local laboratory during screening. * Have measurable disease per RECIST v1.1. * Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1. * Have life expectancy of at least 3 months. * Have adequate organ and bone marrow function as defined in the protocol. Key Exclusion Criteria: * Documentation of known EGFR, KRAS, RET, ROS1, BRAF mutations, NTRK gene infusions, RET arrangement, ALK gene rearrangements, high-level MET amplification, or METex 14 skipping. Note: Subjects harboring such mutations, gene rearrangements or amplifications may be enrolled in the trial, if subjects have received prior approved targeted therapy for such mutations, the subject may still be eligible for this trial. * Treatment with an anti-cancer agent within 28 days prior to acasunlimab administration. * Any investigational agent (including investigational vaccines). * Radiotherapy within 14 days prior to first dose of acasunlimab. Note: palliative radiotherapy will be allowed for local pain control under certain conditions. * Chronic systemic immunosuppressive corticosteroid doses, ie, prednisone \>10 mg daily or a cumulative dose \>150 mg prednisone within 14 days before the first acasunlimab administration. * Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Subject has contraindications to the use of pembrolizumab per local prescribing information. * Subject has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis (interstitial lung disease). * Ongoing or active infection requiring intravenous treatment with anti-infective therapy or any ongoing systemic inflammatory condition requiring further diagnostic work-up or management during screening. * Symptomatic congestive heart failure (grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia. * Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management. * Ongoing or recent (within 6 months) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs. * Subject has a known history of any of the following: 1. Grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment. 2. Myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade. 3. Liver disease (eg, alcoholic hepatitis or non-alcoholic steatohepatitis, drug-related or autoimmune hepatitis, or evidence of hepatic cirrhosis). 4. Organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of acasunlimab. 5. Grade 3 or higher allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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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 metastatic

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco

    Catania, Italy

  • Cancer & Hematology Centers of Western Michigan CHCWM P.C.

    Grand Rapids, Michigan, 49503, United States

  • Centro Clinico Champalimaud

    Lisbon, Portugal

  • Centro Hospitalar Universitário do Porto - Hospital de Santo Antonio

    Porto, Portugal

  • Cheltenham General Hospital

    Cheltenham, United Kingdom

  • Clinica Universidad de Navarra

    Pamplona, Spain

  • Clinica Universidad de Navarra CUN

    Madrid, Spain

  • Department of Internal Medicine II

    Regensburg, Germany

  • Erasmus MC

    Rotterdam, Netherlands

  • Florida Cancer Center

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists - FCS South

    Fort Myers, Florida, 33901, United States

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, Spain

  • Gustave Roussy

    Villejuif, France

  • Henry Ford Cancer Institute

    Detroit, Michigan, 48202, United States

  • Hopital Charles Nicolle Chu Rouen

    Rouen, France

  • Hopital Morvan CHU de Brest

    Brest, France

  • Hopital dInstruction Des Armees Begin

    Saint-Mandé, France

  • Hospital Universitari Vall dHebron

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Spain

  • Hôpital Foch

    Suresnes, France

  • IFO Regina Elena

    Roma, Italy

  • IRCCS Istituto Europeo di Oncologia

    Milan, Italy

  • Institut Bergonie

    Bordeaux, France

  • Institut de Cancerologie Strasbourg Europe (ICANS)

    Strasbourg, France

  • LKI Lungenfachklinik Immenhausen

    Immenhausen, Germany

  • La Maddalena SPA

    Palermo, Italy

  • Leids Universitair Medisch Centrum

    Leiden, Netherlands

  • MD Anderson Cancer Center

    Madrid, Spain

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, Poland

  • Med.Hochschule Hannover Klinik für Pneumologie

    Hanover, Germany

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Netherlands Cancer Institute

    Amsterdam, Netherlands

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

    Olsztyn, Poland

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403, United States

  • The Christie Hospital

    Manchester, United Kingdom

  • UOC Oncoematologia AOU L.Vanvitelli

    Naples, Italy

  • Universitatsklinik Giessen und Marburg Standort Giessen

    Hessen, Germany

  • VU University Medical Center

    Amsterdam, Netherlands

More trials for these conditions

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