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)

NCT06236438 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: M23-7212023-505773-32-00
• Study Type: interventional
• Target: 840
• Locations: 12 countries
• Sites: 61

Brief 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 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. 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer; NSCLC; Livmoniplimab; Budigalimab; Pembrolizumab; Chemotherapy; ABBV-181; ABBV-151

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 21 Months

• Stage 2: Overall Survival (OS)

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

  Up to 55 Months

Secondary Outcomes (12)

• Stage 1: Progression Free Survival (PFS)

  Up to 21 Months

• Stage 1: Duration of Response (DOR)

  Up to 21 Months

• Stage 1: OS

  Up to 21 Months

• Stage 2: PFS

  Up to 55 Months

• Stage 2: BOR of CR/PR

  Up to 55 Months

Study Arms (6)

Stage 1 (Cohort 1): Livmoniplimab Dose A

EXPERIMENTAL

Participants will receive livmoniplimab (dose A)+ budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.

Drug: Livmoniplimab; Drug: Budigalimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Stage 1 (Cohort 2): Livmoniplimab Dose B

EXPERIMENTAL

Participants will receive livmoniplimab (dose B) + budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.

Drug: Livmoniplimab; Drug: Budigalimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Stage 1 (Cohort 3): Budigalimab

EXPERIMENTAL

Participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed.

Drug: Budigalimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Stage 1 (Cohort 4): Pembrolizumab

EXPERIMENTAL

Participants will receive pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.

Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)

EXPERIMENTAL

Participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.

Drug: Livmoniplimab; Drug: Budigalimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Stage 2 (Arm 2): Placebo

EXPERIMENTAL

Participants will receive placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.

Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Interventions

Livmoniplimab DRUG

Intravenously (IV) Infusion

Also known as: ABBV-151

Stage 1 (Cohort 1): Livmoniplimab Dose A; Stage 1 (Cohort 2): Livmoniplimab Dose B; Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)

Cisplatin DRUG

IV Infusion

Stage 1 (Cohort 1): Livmoniplimab Dose A; Stage 1 (Cohort 2): Livmoniplimab Dose B; Stage 1 (Cohort 3): Budigalimab; Stage 1 (Cohort 4): Pembrolizumab; Stage 2 (Arm 1): Livmoniplimab (Dose Optimized); Stage 2 (Arm 2): Placebo

Budigalimab DRUG

IV Infusion

Also known as: ABBV-181

Stage 1 (Cohort 1): Livmoniplimab Dose A; Stage 1 (Cohort 2): Livmoniplimab Dose B; Stage 1 (Cohort 3): Budigalimab; Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)

Pembrolizumab DRUG

IV Infusion

Stage 1 (Cohort 4): Pembrolizumab; Stage 2 (Arm 2): Placebo

Pemetrexed DRUG

IV Infusion

Stage 1 (Cohort 1): Livmoniplimab Dose A; Stage 1 (Cohort 2): Livmoniplimab Dose B; Stage 1 (Cohort 3): Budigalimab; Stage 1 (Cohort 4): Pembrolizumab; Stage 2 (Arm 1): Livmoniplimab (Dose Optimized); Stage 2 (Arm 2): Placebo

Carboplatin DRUG

IV Injection

Stage 1 (Cohort 1): Livmoniplimab Dose A; Stage 1 (Cohort 2): Livmoniplimab Dose B; Stage 1 (Cohort 3): Budigalimab; Stage 1 (Cohort 4): Pembrolizumab; Stage 2 (Arm 1): Livmoniplimab (Dose Optimized); Stage 2 (Arm 2): Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (61)

Moores Cancer Center /ID# 267782

La Jolla, California, 92037, United States

RECRUITING

Memorial Hospital West /ID# 262221

Pembroke Pines, Florida, 33028, United States

RECRUITING

Bond Clinic /ID# 262611

Winter Haven, Florida, 33880, United States

RECRUITING

University Cancer & Blood Cent /ID# 261824

Athens, Georgia, 30607, United States

RECRUITING

The University of Chicago Medical Center /ID# 262259

Chicago, Illinois, 60637-1443, United States

RECRUITING

University of Kansas Medical Center /ID# 263196

Westwood, Kansas, 66205, United States

RECRUITING

Baptist Health Lexington /ID# 261823

Lexington, Kentucky, 40503, United States

RECRUITING

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

Grand Rapids, Michigan, 49546-7062, United States

RECRUITING

Washington University-School of Medicine /ID# 262759

St Louis, Missouri, 63110, United States

RECRUITING

Stony Brook Cancer Center /ID# 261954

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

RECRUITING

Cone Health Cancer Center /ID# 262583

Greensboro, North Carolina, 27403-1109, United States

RECRUITING

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

Cincinnati, Ohio, 45252, United States

RECRUITING

Guthrie Robert Packer Hospital /ID# 262758

Sayre, Pennsylvania, 18840, United States

RECRUITING

Renovatio clinical /ID# 262000

El Paso, Texas, 79915-1803, United States

COMPLETED

Houston Methodist Hospital /ID# 262722

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - Plano East /ID# 264356

Plano, Texas, 75075, United States

RECRUITING

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

San Antonio, Texas, 78240, United States

RECRUITING

Renovatio Clinical /ID# 261999

The Woodlands, Texas, 77380-3181, United States

COMPLETED

Vista Oncology - East Olympia /ID# 262303

Olympia, Washington, 98506-5028, United States

RECRUITING

Canberra Hospital /ID# 261891

Garran, Australian Capital Territory, 2605, Australia

RECRUITING

Nepean Hospital /ID# 262157

Kingswood, New South Wales, 2747, Australia

RECRUITING

Westmead Hospital /ID# 261894

Westmead, New South Wales, 2145, Australia

RECRUITING

Universitair Ziekenhuis Antwerpen /ID# 261270

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Cliniques Universitaires UCL Saint-Luc /ID# 261267

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

Hospital La Louviere Site Jolimont - Helora /ID# 261269

La Louvière, Hainaut, 7100, Belgium

RECRUITING

Groupe Sante CHC - Clinique du MontLegia /ID# 262338

Liège, Liege, 4000, Belgium

RECRUITING

AZ Maria Middelares /ID# 262313

Ghent, 9000, Belgium

RECRUITING

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

Namur, 5000, Belgium

RECRUITING

Oncored /Id# 261801

Vitacura, Region Metropolitana Santiago, 7650027, Chile

RECRUITING

Centro de Investigacion y Desarrollo Oncologico /ID# 261800

Temuco, Región de la Araucanía, 4810218, Chile

RECRUITING

Sociedad Cem-Cancer Spa /Id# 262316

Viña del Mar, Región de Valparaíso, 2520598, Chile

RECRUITING

Fundacion Arturo Lopez Perez /ID# 261700

Providencia, Santiago Metropolitan, 7500921, Chile

RECRUITING

Hospital Clinico Universidad De Los Andes /ID# 262665

Santiago, 7501504, Chile

RECRUITING

APHM - Hopital Nord /ID# 261129

Marseille, Bouches-du-Rhone, 13015, France

RECRUITING

CHU Grenoble - Hopital Michallon /ID# 261131

La Tronche, Isere, 38700, France

RECRUITING

Institut Curie /ID# 261127

Paris, Paris, 75248, France

RECRUITING

Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 261644

Bron, Rhone, 69500, France

RECRUITING

Centre Hosp Intercommunal de Creteil /ID# 261130

Créteil, Val-de-Marne, 94000, France

RECRUITING

Shaare Zedek Medical Center /ID# 262432

Jerusalem, Jerusalem, 91031, Israel

RECRUITING

Rambam Health Care Campus /ID# 262431

Haifa, 3109601, Israel

RECRUITING

National Cancer Center Hospital East /ID# 261923

Kashiwa-shi, Chiba, 277-8577, Japan

RECRUITING

Saitama Prefectural Cancer Center /ID# 262703

Kitaadachi-gun, Saitama, 362-0806, Japan

RECRUITING

National Cancer Center Hospital /ID# 261925

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

Ziekenhuis St. Jansdal /ID# 261193

Harderwijk, Gelderland, 3844 DG, Netherlands

RECRUITING

Zuyderland Medisch Centrum /ID# 261190

Heerlen, Limburg, 6419 PC, Netherlands

RECRUITING

Isala /ID# 262458

Zwolle, Overijssel, 8025 AB, Netherlands

RECRUITING

Pan American Center for Oncology Trials /ID# 269666

Rio Piedras, 00935, Puerto Rico

RECRUITING

Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262723

Santiago de Compostela, A Coruna, 15706, Spain

RECRUITING

Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 262118

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

UOMi Cancer Center - Clinica Tres Torres /ID# 262116

Barcelona, 08017, Spain

RECRUITING

Hospital Universitario Vall de Hebron /ID# 262113

Barcelona, 08035, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon /ID# 262114

Madrid, 28007, Spain

RECRUITING

Hospital Universitario 12 de Octubre /ID# 262112

Madrid, 28041, Spain

RECRUITING

Hospital Clinico Universitario de Valencia /ID# 262115

Valencia, 46010, Spain

RECRUITING

National Cheng Kung University Hospital /ID# 262016

Tainan, 704, Taiwan

RECRUITING

Mackay Memorial Hospital /ID# 262534

Taipei, 104, Taiwan

RECRUITING

Taipei Medical University Hospital /ID# 262020

Taipei, 11031, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital /ID# 262535

Taoyuan, 333, Taiwan

RECRUITING

Gazi University Medical Faculty /ID# 261786

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Ankara City Hospital /ID# 261785

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Dr. Suat Seren Gogus Has /ID# 261789

Izmir, 35110, Turkey (Türkiye)

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

budigalimab; pembrolizumab; Pemetrexed; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: April 10, 2024
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

ES (7); TW (4); TU (3); JP (3); NL (3); AU (3); FR (5); BE (6); CL (5); PR (1); US (19); IL (2)