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New drug cocktail aims to shrink lung tumors without chemo

NCT ID NCT06772623

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 24 times

Summary

This study tests a new drug called telisotuzumab adizutecan (ABBV-400) combined with an immunotherapy drug (budigalimab or pembrolizumab) in people with advanced non-squamous lung cancer who have not had prior treatment. The goal is to find the best dose that is safe and effective. About 252 adults will take part at sites worldwide. The trial has two stages: first, finding a safe dose, then comparing two doses of the new combo against standard chemo-immunotherapy.

What this could mean

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

Active substance
Telisotuzumab adizutecan (ABBV-400) combined with budigalimab or pembrolizumab
What this could lead to
If successful, this could provide a new first-line treatment option for people with advanced non-squamous lung cancer who cannot use targeted therapies.
What could go wrong
This is an early-phase trial (1b/2) with a small number of participants, so the combination may not prove more effective or safer than current standard care. Side effects from the drug combination 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 252 people

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

Started

Mar 2025

Expected to finish

Nov 2027

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: * Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study. * Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1. * For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC. * For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration. * Must have documented programmed death ligand 1 (PD-L1) status. * For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization. * Must have adequate organ function. Exclusion Criteria: * Known uncontrolled metastases to the central nervous system. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.

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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 carcinoma

How to take part

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

  1. The places running it

    117 sites in 15 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

  • AZ-Delta. /ID# 272433

    RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Adana Medical Park Seyhan Hastanesi /ID# 272875

    RECRUITING

    Adana, 01140, Turkey (Türkiye)

  • Aichi Cancer Center /ID# 271978

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 272873

    RECRUITING

    Ankara, 06620, Turkey (Türkiye)

  • Astera Cancer Care /ID# 271915

    RECRUITING

    East Brunswick, New Jersey, 08816-4096, United States

  • Azienda Ospedaliera Complesso Ospedaliero San Giovanni-Addolorata /ID# 273438

    RECRUITING

    Rome, Roma, 00184, Italy

  • Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 268641

    RECRUITING

    Orbassano, Torino, 10043, Italy

  • Azienda Ospedaliero Universitaria delle Marche /ID# 268667

    RECRUITING

    Ancona, 60126, Italy

  • Blacktown Hospital /ID# 281588

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

  • CHU Nantes - Hopital Laennec /ID# 268475

    RECRUITING

    Saint-Herblain, Loire-Atlantique, 44800, France

  • Cancer Hospital - Chinese Academy of Medical Sciences /ID# 269715

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Centre Antoine-Lacassagne /ID# 268486

    RECRUITING

    Nice, Provence-Alpes-Côte d'Azur Region, 06189, France

  • Centre De Cancerologie Du Grand Montpellier /ID# 273724

    RECRUITING

    Montpellier, Occitanie, 34070, France

  • Changhua Christian Hospital /ID# 280139

    RECRUITING

    Changhua, 500, Taiwan

  • Clinica MedLife Polisano Sibiu /ID# 269078

    RECRUITING

    Sibiu, 550253, Romania

  • Community Health Network /ID# 273437

    COMPLETED

    Indianapolis, Indiana, 46202, United States

  • Complejo Hospitalario Universitario A Coruna /ID# 271456

    RECRUITING

    A Coruña, 15006, Spain

  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 268789

    RECRUITING

    Chiayi City, 62247, Taiwan

  • Dana-Farber Cancer Institute /ID# 278417

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450

    RECRUITING

    Oxnard, California, 93030, United States

  • First Affiliated Hospital of Shanxi Medical University /ID# 276482

    RECRUITING

    Taiyuan, Shanxi, 030001, China

  • Fujian Province Cancer Hospital /ID# 269150

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 280635

    RECRUITING

    Istanbul, 34722, Turkey (Türkiye)

  • Groupe Sante CHC - Clinique du MontLegia /ID# 271760

    RECRUITING

    Liège, Liege, 4000, Belgium

  • Gulhane Egitim ve Arastirma Hastanesi /ID# 280715

    RECRUITING

    Ankara, Antalya, 06010, Turkey (Türkiye)

  • Hamatologie-Onkologie im Zentrum MVZ GmbH /ID# 273043

    RECRUITING

    Augsburg, Bavaria, 86150, Germany

  • Henan Cancer Hospital /ID# 269668

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Henry Ford Hospital /ID# 271642

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hirosaki University Hospital /ID# 274410

    RECRUITING

    Hirosaki, Aomori, 036-8563, Japan

  • Hope And Healing Cancer Services /ID# 276223

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Hospital Clinic de Barcelona /ID# 271452

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario de Alicante Doctor Balmis /ID# 271316

    RECRUITING

    Alicante, 03010, Spain

  • Hospital Santa Creu i Sant Pau /ID# 271311

    RECRUITING

    Barcelona, 08041, Spain

  • Hospital Universitario Marques de Valdecilla /ID# 271314

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen Macarena /ID# 271447

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Hospital Universitario Virgen de la Victoria /ID# 271312

    RECRUITING

    Málaga, 29010, Spain

  • Hunan Province Cancer Hospital /ID# 269679

    RECRUITING

    Changsha, Hunan, 410013, China

  • Huntsman Cancer Institute /ID# 271686

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 268675

    RECRUITING

    Bologna, 40138, Italy

  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 268626

    RECRUITING

    Rome, Roma, 00144, Italy

  • Institut Bergonie /ID# 258377

    RECRUITING

    Bordeaux, Gironde, 33000, France

  • Institut Curie /ID# 271395

    RECRUITING

    Paris, Île-de-France Region, 75248, France

  • Institut Gustave Roussy /ID# 258373

    RECRUITING

    Villejuif, Val-de-Marne, 94805, France

  • Institut de Cancerologie de l'Ouest Rene Gauducheau /ID# 268484

    RECRUITING

    Saint-Herblain, Loire-Atlantique, 44805, France

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca /ID# 268725

    RECRUITING

    Cluj-Napoca, Cluj, 400015, Romania

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca /ID# 273125

    RECRUITING

    Cluj-Napoca, Cluj, 400015, Romania

  • Istituto Europeo Di Oncologia /Id# 268670

    RECRUITING

    Milan, Milano, 20121, Italy

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 268684

    RECRUITING

    Meldola, Forlì-Cesena, 47014, Italy

  • Jessa Ziekenhuis - Campus Virga Jesse /ID# 268573

    RECRUITING

    Hasselt, Limburg, 3500, Belgium

  • Joe Arrington Cancer Research /ID# 272776

    RECRUITING

    Lubbock, Texas, 79410-1121, United States

  • Kansas City Cancer Center /ID# 273679

    RECRUITING

    Overland Park, Kansas, 66210, United States

  • Kaohsiung Chang Gung Memorial Hospital /ID# 268138

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 268139

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Kyoto University Hospital /ID# 272312

    RECRUITING

    Kyoto, Kyoto, 606-8507, Japan

  • Linkou Chang Gung Memorial Hospital /ID# 268137

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Liuzhou People's hospital /ID# 269667

    RECRUITING

    Liuzhou, Guangxi, 545006, China

  • Liv Hospital Ankara /ID# 272876

    RECRUITING

    Ankara, 06680, Turkey (Türkiye)

  • Lungenklinik Hemer /ID# 269779

    RECRUITING

    Hemer, North Rhine-Westphalia, 58675, Germany

  • MNT Healthcare Europe SRL /ID# 269075

    RECRUITING

    Bucharest, 013975, Romania

  • Mayo Clinic Hospital - Phoenix /ID# 272971

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Hospital Jacksonville /ID# 275073

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic-Rochester /ID# 274512

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mid Florida Hematology And Oncology Center /ID# 273777

    RECRUITING

    Orange City, Florida, 32763, United States

  • Millennium Physicians /ID# 271717

    COMPLETED

    Houston, Texas, 77090, United States

  • NHO Nagoya Medical Center /ID# 272515

    RECRUITING

    Nagoya, Aichi-ken, 460-0001, Japan

  • Nagasaki University Hospital /ID# 273310

    RECRUITING

    Nagasaki, 852-8501, Japan

  • Nanjing Drum Tower Hospital /ID# 269762

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • National Cancer Center Hospital /ID# 273192

    RECRUITING

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Taiwan University Cancer Center (Ntucc) /ID# 271586

    RECRUITING

    Taipei, 106, Taiwan

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi - Eski Hastane /ID# 272882

    RECRUITING

    Konya, 42080, Turkey (Türkiye)

  • New York Cancer And Blood Specialists - Shirley /ID# 272547

    RECRUITING

    Shirley, New York, 11967, United States

  • Niigata University Medical and Dental Hospital /ID# 274448

    RECRUITING

    Niigata, Niigata, 951-8520, Japan

  • Northwest Medical Specialties Tacoma /ID# 270469

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Ondokuz Mayis Universitesi /ID# 272899

    RECRUITING

    Samsun, 55139, Turkey (Türkiye)

  • Osaka Medical And Pharmaceutical University Hospital /ID# 273309

    RECRUITING

    Takatsuki, Osaka, 569-8686, Japan

  • Pamukkale Universitesi /ID# 272893

    RECRUITING

    Denizli, 20070, Turkey (Türkiye)

  • Pan American Center for Oncology Trials - Rio Piedras /ID# 268827

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Parc de Salut Mar - Hospital del Mar /ID# 271310

    RECRUITING

    Barcelona, 08003, Spain

  • Parkview Comprehensive Cancer Center /ID# 271879

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Peninsula University Hospital /ID# 281824

    RECRUITING

    Frankston, Victoria, 3199, Australia

  • Providence - St. Jude Medical Center /ID# 271414

    RECRUITING

    Fullerton, California, 92835, United States

  • Rocky Mountain Cancer Centers - Lone Tree /ID# 272603

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • S.C. Radiotherapy Center Cluj SRL /ID# 268729

    RECRUITING

    Cluj-Napoca, Cluj, 400080, Romania

  • Sakarya Egitim ve Arastirma Hastanesi /ID# 272878

    RECRUITING

    Adapazarı, Sakarya, 54290, Turkey (Türkiye)

  • Samsun Medical Park Hastanesi /ID# 272880

    RECRUITING

    Samsun, 55200, Turkey (Türkiye)

  • Shanghai Chest Hospital /ID# 269155

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Shanghai Pulmonary Hospital /ID# 276397

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Sichuan Cancer Hospital /ID# 269712

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Slk-Kliniken Heilbronn /ID# 269621

    RECRUITING

    Heilbronn, Baden-Wurttemberg, 74078, Germany

  • Spitalul Clinic Coltea /ID# 268726

    RECRUITING

    Bucharest, 030171, Romania

  • Spoknwrd Clinical Trials /ID# 273776

    RECRUITING

    Easton, Pennsylvania, 18045, United States

  • St. Luke'S /ID# 273344

    RECRUITING

    Duluth, Minnesota, 55805, United States

  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 274549

    RECRUITING

    Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

  • Taipei Veterans General Hospital /ID# 268787

    RECRUITING

    Taipei, 112, Taiwan

  • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 271989

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • The First Affiliated Hospital of Nanchang University /ID# 269190

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271904

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The Mark H Zangmeister Center /ID# 272502

    RECRUITING

    Columbus, Ohio, 43219, United States

  • Townsville University Hospital /ID# 281498

    RECRUITING

    Townsville, Queensland, 4814, Australia

  • Tri-Service General Hospital /ID# 269211

    RECRUITING

    Taipei, 114, Taiwan

  • UCLA - Santa Monica /ID# 271690

    RECRUITING

    Santa Monica, California, 90404, United States

  • Union Hospital - Tongji Medical College /ID# 272286

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Universitaetsklinikum Frankfurt /ID# 268721

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Universitaetsklinikum Freiburg /ID# 268473

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Koeln /ID# 268489

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitaetsklinikum Wuerzburg /ID# 275445

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Universitatsklinikum Jena /ID# 269700

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • University Hospitals Cleveland Medical Center /ID# 271726

    COMPLETED

    Cleveland, Ohio, 44106, United States

  • University Hospitals of Leicester NHS Trust /ID# 276035

    RECRUITING

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • University Of Colorado - Anschutz Medical Campus /ID# 269069

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 273170

    RECRUITING

    Lublin, Lublin Voivodeship, 20-090, Poland

  • Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 276848

    RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-540, Poland

  • Uniwersyteckie Centrum Kliniczne /ID# 272418

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Velindre Cancer Centre /ID# 271840

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Virgnia Cancer Specialists /ID# 269633

    RECRUITING

    Leesburg, Virginia, 20176, United States

  • Vista Oncology - East Olympia /ID# 275438

    RECRUITING

    Olympia, Washington, 98506, United States

  • Vitaz /Id# 280187

    RECRUITING

    Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

  • West China Hospital of Sichuan University /ID# 270244

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Yokohama Municipal Citizen's Hospital /ID# 271979

    RECRUITING

    Yokohama, Kanagawa, 221-0855, Japan

  • Yunnan Province Cancer Hospital /ID# 272331

    RECRUITING

    Kunming, Yunnan, 650106, China

  • ohO Research GmbH /ID# 273060

    RECRUITING

    Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

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