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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 · AbbVie
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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)
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 840 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-04-10
Estimated completion: 2031-10
Last updated: 2026-02-23
Interventions
Drug: LivmoniplimabDrug: BudigalimabDrug: PembrolizumabDrug: PemetrexedDrug: CisplatinDrug: CarboplatinDrug: Carboplatin
Primary outcomes
  • Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) (Up to 21 Months)
  • Stage 2: Overall Survival (OS) (Up to 55 Months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (61)
Moores Cancer Center /ID# 267782Recruiting
La Jolla, California, United States
Memorial Hospital West /ID# 262221Recruiting
Pembroke Pines, Florida, United States
Bond Clinic /ID# 262611Recruiting
Winter Haven, Florida, United States
University Cancer & Blood Cent /ID# 261824Recruiting
Athens, Georgia, United States
The University of Chicago Medical Center /ID# 262259Recruiting
Chicago, Illinois, United States
University of Kansas Medical Center /ID# 263196Recruiting
Westwood, Kansas, United States
Baptist Health Lexington /ID# 261823Recruiting
Lexington, Kentucky, United States
Cancer & Hematology Centers of Western Michigan - East /ID# 261826Recruiting
Grand Rapids, Michigan, United States
Washington University-School of Medicine /ID# 262759Recruiting
St Louis, Missouri, United States
Stony Brook Cancer Center /ID# 261954Recruiting
Stony Brook, New York, United States
Cone Health Cancer Center /ID# 262583Recruiting
Greensboro, North Carolina, United States
Oncology Hematology Care, Inc - Blue Ash /ID# 262733Recruiting
Cincinnati, Ohio, United States
Guthrie Robert Packer Hospital /ID# 262758Recruiting
Sayre, Pennsylvania, United States
Renovatio clinical /ID# 262000Completed
El Paso, Texas, United States
Houston Methodist Hospital /ID# 262722Recruiting
Houston, Texas, United States
Texas Oncology - Plano East /ID# 264356Recruiting
Plano, Texas, United States
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 264311Recruiting
San Antonio, Texas, United States
Renovatio Clinical /ID# 261999Completed
The Woodlands, Texas, United States
Vista Oncology - East Olympia /ID# 262303Recruiting
Olympia, Washington, United States
Canberra Hospital /ID# 261891Recruiting
Garran, Australian Capital Territory, Australia
Nepean Hospital /ID# 262157Recruiting
Kingswood, New South Wales, Australia
Westmead Hospital /ID# 261894Recruiting
Westmead, New South Wales, Australia
Universitair Ziekenhuis Antwerpen /ID# 261270Recruiting
Edegem, Antwerpen, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 261267Recruiting
Brussels, Brussels Capital, Belgium
Hospital La Louviere Site Jolimont - Helora /ID# 261269Recruiting
La Louvière, Hainaut, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 262338Recruiting
Liège, Liege, Belgium
AZ Maria Middelares /ID# 262313Recruiting
Ghent, Belgium
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 262557Recruiting
Namur, Belgium
Centro de Investigacion y Desarrollo Oncologico /ID# 261800Recruiting
Temuco, Araucania, Chile
Oncored /Id# 261801Recruiting
Vitacura, Region Metropolitana Santiago, Chile
Fundacion Arturo Lopez Perez /ID# 261700Recruiting
Providencia, Santiago Metropolitan, Chile
Sociedad Cem-Cancer Spa /Id# 262316Recruiting
Viña del Mar, Valparaiso, Chile
Hospital Clinico Universidad De Los Andes /ID# 262665Recruiting
Santiago, Chile
APHM - Hopital Nord /ID# 261129Recruiting
Marseille, Bouches-du-Rhone, France
CHU Grenoble - Hopital Michallon /ID# 261131Recruiting
La Tronche, Isere, France
Institut Curie /ID# 261127Recruiting
Paris, Paris, France
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 261644Recruiting
Bron, Rhone, France
Centre Hosp Intercommunal de Creteil /ID# 261130Recruiting
Créteil, Val-de-Marne, France
Shaare Zedek Medical Center /ID# 262432Recruiting
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus /ID# 262431Recruiting
Haifa, Israel
National Cancer Center Hospital East /ID# 261923Recruiting
Kashiwa-shi, Chiba, Japan
Saitama Prefectural Cancer Center /ID# 262703Recruiting
Kitaadachi-gun, Saitama, Japan
National Cancer Center Hospital /ID# 261925Recruiting
Chuo-ku, Tokyo, Japan
Ziekenhuis St. Jansdal /ID# 261193Recruiting
Harderwijk, Gelderland, Netherlands
Zuyderland Medisch Centrum /ID# 261190Recruiting
Heerlen, Limburg, Netherlands
Isala /ID# 262458Recruiting
Zwolle, Overijssel, Netherlands
Pan American Center for Oncology Trials /ID# 269666Recruiting
Rio Piedras, Puerto Rico
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262723Recruiting
Santiago de Compostela, A Coruna, Spain
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 262118Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
UOMi Cancer Center - Clinica Tres Torres /ID# 262116Recruiting
Barcelona, Spain
Hospital Universitario Vall de Hebron /ID# 262113Recruiting
Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 262114Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 262112Recruiting
Madrid, Spain
Hospital Clinico Universitario de Valencia /ID# 262115Recruiting
Valencia, Spain
National Cheng Kung University Hospital /ID# 262016Recruiting
Tainan, Taiwan
Mackay Memorial Hospital /ID# 262534Recruiting
Taipei, Taiwan
Taipei Medical University Hospital /ID# 262020Recruiting
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 262535Recruiting
Taoyuan City, Taiwan
Gazi University Medical Faculty /ID# 261786Recruiting
Ankara, Turkey (Türkiye)
Ankara City Hospital /ID# 261785Recruiting
Ankara, Turkey (Türkiye)
Dr. Suat Seren Gogus Has /ID# 261789Recruiting
Izmir, Turkey (Türkiye)
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) · TrialPath