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Non-Small Cell Lung CancerPhase 2/3LIVIGNO-4NCT06236438

Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

A Phase 2/3 study testing Livmoniplimab, Budigalimab and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by AbbVie at 61 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Livmoniplimab, Budigalimab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
61 sitesin 12 countries
Study dates
10 Apr 2024to Oct 2031
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Received prior systemic therapy for the treatment of metastatic NSCLC.

Trial locations and contacts

61 sites in 12 countries.

61 sites in 12 countries

United States19 sites

  • University Cancer and Blood Cent /ID# 261824

    Athens, Georgia, 30607

  • The University of Chicago Medical Center /ID# 262259

    Chicago, Illinois, 60637-1443

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

    Cincinnati, Ohio, 45252

  • Renovatio clinical /ID# 262000

    El Paso, Texas, 79915-1803

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

    Grand Rapids, Michigan, 49546-7062

  • Cone Health Cancer Center /ID# 262583

    Greensboro, North Carolina, 27403-1109

  • Houston Methodist Hospital /ID# 262722

    Houston, Texas, 77030

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

    La Jolla, California, 92037

  • Baptist Health Lexington /ID# 261823

    Lexington, Kentucky, 40503

  • Vista Oncology - East Olympia /ID# 262303

    Olympia, Washington, 98506-5028

  • Memorial Hospital West /ID# 262221

    Pembroke Pines, Florida, 33028

  • Texas Oncology - Plano East /ID# 264356

    Plano, Texas, 75075

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

    San Antonio, Texas, 78240

  • Guthrie Robert Packer Hospital /ID# 262758

    Sayre, Pennsylvania, 18840

  • Washington University School Of Medicine - Siteman Cancer Center /ID# 262759

    St Louis, Missouri, 63110

  • Stony Brook Cancer Center /ID# 261954

    Stony Brook, New York, 11794-0001

  • Renovatio Clinical /ID# 261999

    The Woodlands, Texas, 77380-3181

  • University of Kansas Medical Center /ID# 263196

    Westwood, Kansas, 66205

  • Bond Clinic /ID# 262611

    Winter Haven, Florida, 33880

Other trials in United States

Spain7 sites

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

    Barcelona, 08017

  • Hospital Universitario Vall de Hebron /ID# 262113

    Barcelona, 08035

  • Institut Catala dOncologia - LHospitalet /ID# 262118

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital General Universitario Gregorio Maranon /ID# 262114

    Madrid, 28007

  • Hospital Universitario 12 de Octubre /ID# 262112

    Madrid, 28041

  • Complejo Hospitalario Universitario de Santiago /ID# 262723

    Santiago de Compostela, A Coruna, 15706

  • Hospital Clinico Universitario de Valencia /ID# 262115

    Valencia, 46010

Other trials in Spain

Belgium6 sites

  • Cliniques Universitaires UCL Saint-Luc /ID# 261267

    Brussels, Brussels Capital, 1200

  • Universitair Ziekenhuis Antwerpen /ID# 261270

    Edegem, Antwerpen, 2650

  • AZ Maria Middelares /ID# 262313

    Ghent, 9000

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

    La Louvière, Hainaut, 7100

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

    Liège, 4000

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

    Namur, 5000

Other trials in Belgium

Chile5 sites

  • Fundacion Arturo Lopez Perez /ID# 261700

    Providencia, Santiago Metropolitan, 7500921

  • Hospital Clinico Universidad De Los Andes /ID# 262665

    Santiago, 7501504

  • Centro de Investigacion y Desarrollo Oncologico /ID# 261800

    Temuco, Araucania, 4810218

  • Sociedad Cem-Cancer Spa /Id# 262316

    Viña del Mar, Valparaiso, 2520598

  • Oncored /Id# 261801

    Vitacura, Region Metropolitana Santiago, 7650027

Other trials in Chile

France5 sites

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

    Bron, Rhone, 69500

  • Centre Hosp Intercommunal de Creteil /ID# 261130

    Créteil, Val-de-Marne, 94000

  • CHU Grenoble - Hopital Michallon /ID# 261131

    La Tronche, Isere, 38700

  • Assistance Publique Hopitaux de Marseille - Hopital Nord /ID# 261129

    Marseille, Bouches-du-Rhone, 13915

  • Institut Curie /ID# 261127

    Paris, Paris, 75248

Other trials in France

Taiwan4 sites

  • National Cheng Kung University Hospital /ID# 262016

    Tainan, 704

  • Mackay Memorial Hospital /ID# 262534

    Taipei, 104

  • Taipei Medical University Hospital /ID# 262020

    Taipei, 11031

  • Linkou Chang Gung Memorial Hospital /ID# 262535

    Taoyuan City, 333

Other trials in Taiwan

Australia3 sites

  • Canberra Hospital /ID# 261891

    Garran, Australian Capital Territory, 2605

  • Nepean Hospital /ID# 262157

    Kingswood, New South Wales, 2747

  • Westmead Hospital /ID# 261894

    Westmead, New South Wales, 2145

Other trials in Australia

Japan3 sites

  • National Cancer Center Hospital /ID# 261925

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 261923

    Kashiwa-shi, Chiba, 277-8577

  • Saitama Prefectural Cancer Center /ID# 262703

    Kitaadachi-gun, Saitama, 362-0806

Other trials in Japan

Netherlands3 sites

  • Ziekenhuis St. Jansdal /ID# 261193

    Harderwijk, Gelderland, 3844 DG

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

    Heerlen, Limburg, 6419 PC

  • Isala /ID# 262458

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Turkey (Türkiye)3 sites

  • Gazi University Medical Faculty /ID# 261786

    Ankara, 06560

  • Ankara City Hospital /ID# 261785

    Ankara, 06800

  • Dr. Suat Seren Gogus Has /ID# 261789

    Izmir, 35110

Other trials in Turkey (Türkiye)

Israel2 sites

  • Rambam Health Care Campus /ID# 262431

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 262432

    Jerusalem, Jerusalem, 91031

Other trials in Israel

Puerto Rico1 site

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

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer.

Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide.

Read more

Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will receive livmoniplimab (dose B) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In cohort 3, participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed . In cohort 4, participants will receive IV Infused pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. Stage 2: In arm 1, participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Being tested
Livmoniplimab, Budigalimab, Pembrolizumab, Pemetrexed, Cisplatin
Keywords
Non-Small Cell Lung Cancer, Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer, NSCLC, Livmoniplimab, Budigalimab, Pembrolizumab, Chemotherapy, ABBV-181, ABBV-151
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06236438
Study groupRoleWhat they receive
Stage 1 (Cohort 1): Livmoniplimab Dose AExperimentalParticipants will receive livmoniplimab (dose A)+ budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.
Receives: Drug: Livmoniplimab; Drug: Budigalimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
Stage 1 (Cohort 2): Livmoniplimab Dose BExperimentalParticipants will receive livmoniplimab (dose B) + budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.
Receives: Drug: Livmoniplimab; Drug: Budigalimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
Stage 1 (Cohort 3): BudigalimabExperimentalParticipants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed.
Receives: Drug: Budigalimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
Stage 1 (Cohort 4): PembrolizumabExperimentalParticipants will receive pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.
Receives: Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)ExperimentalParticipants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.
Receives: Drug: Livmoniplimab; Drug: Budigalimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
Stage 2 (Arm 2): PlaceboExperimentalParticipants will receive placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.
Receives: Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)

    BOR of CR/PR is defined as achieving CR or PR according to response evaluation criteria in solid tumors (RECIST) v1.1 as determined by investigators at any time prior to subsequent anticancer therapy. Objective response rate (ORR), defined as the percentage of participants with a BOR of CR/PR, will be summarized.

    Measured: Up to 21 Months

  2. Stage 2: Overall Survival (OS)

    OS is defined as the time measured from randomization until death from any cause.

    Measured: Up to 55 Months

Secondary outcomes (12)

  1. Stage 1: Progression Free Survival (PFS)

    PFS is defined as the time measured from randomization until the first documentation of progressive disease (PD) according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

    Measured: Up to 21 Months

  2. Stage 1: Duration of Response (DOR)

    DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

    Measured: Up to 21 Months

  3. Stage 1: OS

    OS is defined as the time measured from randomization until death from any cause.

    Measured: Up to 21 Months

  4. Stage 2: PFS

    PFS is defined as the time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.

    Measured: Up to 55 Months

  5. Stage 2: BOR of CR/PR

    BOR of CR/PR is defined as achieving CR or PR according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy. ORR, defined as the percentage of participants with a BOR of CR/PR, will be summarized.

    Measured: Up to 55 Months

  6. Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17)

    The EORTC QLQ-F17, a shorter, 17-item version that includes only the functional scales and the Global Health Status / Quality of Life scale of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Participants rate items on a 4 point scale ranging form 1 to 4 (1- Not at All, 2= A Little, 3 = Quite a Bit, and 4= Very Much).

    Measured: Up to 55 Months

  7. Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

    The NSCLC -SAQ scale with seven items assessing 5 symptoms of NSCLC (cough, pain, dyspnea, fatigue and poor appetites). The recall period is "over the last 7 days." Each item has a 5-point verbal rating scale from either 0 "No <symptom> at All" to 4 "Very severe <symptom>" or from 0 "Never" to 4 "Always," depending on the item's format.

    Measured: Up to 55 Months

  8. Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17

    The EORTC QLQ-F17, a shorter, 17-item version that includes only the functional scales and the Global Health Status / Quality of Life scale of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Participants rate items on a 4 point scale ranging form 1 to 4 (1- Not at All, 2= A Little, 3 = Quite a Bit, and 4= Very Much).

    Measured: Up to 55 Months

  9. Stage 2: PFS per Investigator

    PFS is defined as the time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by the investigator or death from any cause, whichever occurs first.

    Measured: Up to 55 Months

  10. Stage 1: BOR of CR/PR per Investigator

    BOR of CR/PR is defined as achieving CR or PR according to RECIST 1.1 as determined by investigators. ORR, defined as the percentage of participants with a BOR of CR/PR, will be summarized.

    Measured: Up to 21 Months

  11. Stage 2: DOR

    DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by BICR or death from any cause, whichever occurs first.

    Measured: Up to 55 Months

  12. Stage 2: DOR per investigator

    DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

    Measured: Up to 55 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start10 Apr 2024
  3. Primary completionOct 2031 (estimated)
  4. Study completionOct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06236438
Sponsor's protocol ID
M23-721
Other IDs
2023-505773-32-00, 2023
Acronym
LIVIGNO-4
Status last verified
Oct 2026
First submitted
24 Jan 2024
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Livmoniplimab, Budigalimab and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by AbbVie at 61 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Spain, Belgium, Chile, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) (time frame: Up to 21 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06236438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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LIVIGNO-4 Clinical Trial NCT06236438 | AzTrials