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New drug cocktail aims to outperform standard lung cancer therapy

NCT ID NCT06236438

Disease control Sponsor: AbbVie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 15, 2026 · Updated 8 times

Summary

This study tests whether two experimental drugs (livmoniplimab and budigalimab) combined with chemotherapy work better than the current standard treatment (pembrolizumab plus chemo) for people with untreated metastatic non-squamous non-small cell lung cancer. About 840 adults will take part across 200 sites worldwide. The trial has two stages: first to find the best dose, then to compare the new combo against standard care.

What this could mean

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

Active substance
livmoniplimab and budigalimab (investigational drugs) plus chemotherapy (pemetrexed and cisplatin or carboplatin)
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with metastatic non-squamous lung cancer, potentially improving response rates and survival.
What could go wrong
This is an early-to-mid stage trial; the experimental drugs may not work better than the current standard, and side effects could be more burdensome. Results are years away.

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 840 people

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

Started

Apr 2024

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.

Inclusion Criteria: * Diagnosis of histologically or cytologically confirmed metastatic nonsquamous non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) mutation, or other genomic aberration for which a locally approved targeted therapy is available. * Must have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by the local site Investigator/radiology assessment. * Life expectancy of at least 3 months and adequate organ function. Exclusion Criteria: \- Received prior systemic therapy for the treatment of metastatic NSCLC.

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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

How to take part

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

  1. The places running it

    52 sites in 12 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

  • APHM - Hopital Nord /ID# 261129

    RECRUITING

    Marseille, Bouches-du-Rhone, 13015, France

  • AZ Maria Middelares /ID# 262313

    RECRUITING

    Ghent, 9000, Belgium

  • Ankara City Hospital /ID# 261785

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Atrium-Orbis - Zuyderland Medisch Centrum Heerlen /ID# 261190

    RECRUITING

    Heerlen, Limburg, 6419 PC, Netherlands

  • Baptist Health Lexington /ID# 261823

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Bond Clinic /ID# 262611

    RECRUITING

    Winter Haven, Florida, 33880, United States

  • CHU Grenoble - Hopital Michallon /ID# 261131

    RECRUITING

    La Tronche, Isere, 38700, France

  • Canberra Hospital /ID# 261891

    RECRUITING

    Garran, Australian Capital Territory, 2605, Australia

  • Cancer & Hematology Centers of Western Michigan - East /ID# 261826

    RECRUITING

    Grand Rapids, Michigan, 49546-7062, United States

  • Centre Hosp Intercommunal de Creteil /ID# 261130

    RECRUITING

    Créteil, Val-de-Marne, 94000, France

  • Centro de Investigacion y Desarrollo Oncologico /ID# 261800

    RECRUITING

    Temuco, Araucania, 4810218, Chile

  • Cliniques Universitaires UCL Saint-Luc /ID# 261267

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Complejo Hospitalario Universitario de Santiago /ID# 262723

    RECRUITING

    Santiago de Compostela, A Coruna, 15706, Spain

  • Cone Health Cancer Center /ID# 262583

    COMPLETED

    Greensboro, North Carolina, 27403-1109, United States

  • Dr. Suat Seren Gogus Has /ID# 261789

    RECRUITING

    Izmir, 35110, Turkey (Türkiye)

  • Fundacion Arturo Lopez Perez /ID# 261700

    RECRUITING

    Providencia, Santiago Metropolitan, 7500921, Chile

  • Gazi University Medical Faculty /ID# 261786

    RECRUITING

    Ankara, 06560, Turkey (Türkiye)

  • Groupe Sante CHC - Clinique du MontLegia /ID# 262338

    RECRUITING

    Liège, Liege, 4000, Belgium

  • Guthrie Robert Packer Hospital /ID# 262758

    COMPLETED

    Sayre, Pennsylvania, 18840, United States

  • Hospices Civils de Lyon - Hopital Louis Pradel /ID# 261644

    RECRUITING

    Bron, Rhone, 69500, France

  • Hospital Clinico Universidad De Los Andes /ID# 262665

    COMPLETED

    Santiago, 7501504, Chile

  • Hospital Clinico Universitario de Valencia /ID# 262115

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon /ID# 262114

    RECRUITING

    Madrid, 28007, Spain

  • Hospital La Louviere Site Jolimont - Helora /ID# 261269

    COMPLETED

    La Louvière, Hainaut, 7100, Belgium

  • Hospital Universitario 12 de Octubre /ID# 262112

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Vall de Hebron /ID# 262113

    RECRUITING

    Barcelona, 08035, Spain

  • Houston Methodist Hospital /ID# 262722

    RECRUITING

    Houston, Texas, 77030, United States

  • Institut Catala dOncologia - LHospitalet /ID# 262118

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Institut Curie /ID# 261127

    RECRUITING

    Paris, Paris, 75248, France

  • Isala /ID# 262458

    RECRUITING

    Zwolle, Overijssel, 8025 AB, Netherlands

  • Linkou Chang Gung Memorial Hospital /ID# 262535

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Mackay Memorial Hospital /ID# 262534

    RECRUITING

    Taipei, 104, Taiwan

  • Memorial Hospital West /ID# 262221

    COMPLETED

    Pembroke Pines, Florida, 33028, United States

  • National Cancer Center Hospital /ID# 261925

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 261923

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital /ID# 262016

    RECRUITING

    Tainan, 704, Taiwan

  • Nepean Hospital /ID# 262157

    RECRUITING

    Kingswood, New South Wales, 2747, Australia

  • Oncology Hematology Care, Inc - Blue Ash /ID# 262733

    RECRUITING

    Cincinnati, Ohio, 45252, United States

  • Oncored /Id# 261801

    RECRUITING

    Vitacura, Region Metropolitana Santiago, 7650027, Chile

  • Pan American Center for Oncology Trials - Rio Piedras /ID# 269666

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Rambam Health Care Campus /ID# 262431

    RECRUITING

    Haifa, 3109601, Israel

  • Renovatio Clinical /ID# 261999

    COMPLETED

    The Woodlands, Texas, 77380-3181, United States

  • Renovatio clinical /ID# 262000

    COMPLETED

    El Paso, Texas, 79915-1803, United States

  • Saitama Prefectural Cancer Center /ID# 262703

    RECRUITING

    Kitaadachi-gun, Saitama, 362-0806, Japan

  • Shaare Zedek Medical Center /ID# 262432

    RECRUITING

    Jerusalem, Jerusalem, 91031, Israel

  • Sociedad Cem-Cancer Spa /Id# 262316

    RECRUITING

    Viña del Mar, Valparaiso, 2520598, Chile

  • Stony Brook Cancer Center /ID# 261954

    COMPLETED

    Stony Brook, New York, 11794-0001, United States

  • Taipei Medical University Hospital /ID# 262020

    RECRUITING

    Taipei, 11031, Taiwan

  • Texas Oncology - Plano East /ID# 264356

    RECRUITING

    Plano, Texas, 75075, United States

  • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 264311

    RECRUITING

    San Antonio, Texas, 78240, United States

  • The University of Chicago Medical Center /ID# 262259

    RECRUITING

    Chicago, Illinois, 60637-1443, United States

  • UC San Diego Health - Moores Cancer Center /ID# 267782

    COMPLETED

    La Jolla, California, 92037, United States

  • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 262557

    RECRUITING

    Namur, 5000, Belgium

  • UOMi Cancer Center - Clinica Tres Torres /ID# 262116

    RECRUITING

    Barcelona, 08017, Spain

  • Universitair Ziekenhuis Antwerpen /ID# 261270

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • University Cancer and Blood Cent /ID# 261824

    RECRUITING

    Athens, Georgia, 30607, United States

  • University of Kansas Medical Center /ID# 263196

    RECRUITING

    Westwood, Kansas, 66205, United States

  • Vista Oncology - East Olympia /ID# 262303

    RECRUITING

    Olympia, Washington, 98506-5028, United States

  • Washington University-School of Medicine /ID# 262759

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Westmead Hospital /ID# 261894

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Ziekenhuis St. Jansdal /ID# 261193

    RECRUITING

    Harderwijk, Gelderland, 3844 DG, Netherlands

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