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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rozpoznaniem zaawansowanego raka płuca (typu non-squamous NSCLC) bez wcześniejszego leczenia systemowego
- •Obecność przynajmniej jednego widocznego guza możliwego do zmierzenia w badaniach obrazowych
- •Spodziewana długość życia co najmniej 3 miesiące
- •Prawidłowa funkcja narządów wewnętrznych
✗ Disqualifies
- •Wcześniejsze otrzymanie terapii systemowej na raka płuca
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (61)
UC San Diego Health - Moores Cancer Center /ID# 267782
La Jolla, United States
Memorial Hospital West /ID# 262221
Pembroke Pines, United States
Bond Clinic /ID# 262611
Winter Haven, United States
University Cancer and Blood Cent /ID# 261824
Athens, United States
The University of Chicago Medical Center /ID# 262259
Chicago, United States
University of Kansas Medical Center /ID# 263196
Westwood, United States
Baptist Health Lexington /ID# 261823
Lexington, United States
Cancer & Hematology Centers of Western Michigan - East /ID# 261826
Grand Rapids, United States
Washington University-School of Medicine /ID# 262759
St Louis, United States
Stony Brook Cancer Center /ID# 261954
Stony Brook, United States
Cone Health Cancer Center /ID# 262583
Greensboro, United States
Oncology Hematology Care, Inc - Blue Ash /ID# 262733
Cincinnati, United States
Guthrie Robert Packer Hospital /ID# 262758
Sayre, United States
Renovatio clinical /ID# 262000
El Paso, United States
Houston Methodist Hospital /ID# 262722
Houston, United States
Texas Oncology - Plano East /ID# 264356
Plano, United States
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 264311
San Antonio, United States
Renovatio Clinical /ID# 261999
The Woodlands, United States
Vista Oncology - East Olympia /ID# 262303
Olympia, United States
Canberra Hospital /ID# 261891
Garran, Australia
Nepean Hospital /ID# 262157
Kingswood, Australia
Westmead Hospital /ID# 261894
Westmead, Australia
Universitair Ziekenhuis Antwerpen /ID# 261270
Edegem, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 261267
Brussels, Belgium
Hospital La Louviere Site Jolimont - Helora /ID# 261269
La Louvière, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 262338
Liège, Belgium
AZ Maria Middelares /ID# 262313
Ghent, Belgium
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 262557
Namur, Belgium
Centro de Investigacion y Desarrollo Oncologico /ID# 261800
Temuco, Chile
Oncored /Id# 261801
Vitacura, Chile
Fundacion Arturo Lopez Perez /ID# 261700
Providencia, Chile
Sociedad Cem-Cancer Spa /Id# 262316
Viña del Mar, Chile
Hospital Clinico Universidad De Los Andes /ID# 262665
Santiago, Chile
APHM - Hopital Nord /ID# 261129
Marseille, France
CHU Grenoble - Hopital Michallon /ID# 261131
La Tronche, France
Institut Curie /ID# 261127
Paris, France
Hospices Civils de Lyon - Hopital Louis Pradel /ID# 261644
Bron, France
Centre Hosp Intercommunal de Creteil /ID# 261130
Créteil, France
Shaare Zedek Medical Center /ID# 262432
Jerusalem, Israel
Rambam Health Care Campus /ID# 262431
Haifa, Israel
National Cancer Center Hospital East /ID# 261923
Kashiwa-shi, Japan
Saitama Prefectural Cancer Center /ID# 262703
Kitaadachi-gun, Japan
National Cancer Center Hospital /ID# 261925
Chuo-ku, Japan
Ziekenhuis St. Jansdal /ID# 261193
Harderwijk, Netherlands
Atrium-Orbis - Zuyderland Medisch Centrum Heerlen /ID# 261190
Heerlen, Netherlands
Isala /ID# 262458
Zwolle, Netherlands
Pan American Center for Oncology Trials - Rio Piedras /ID# 269666
Rio Piedras, Puerto Rico
Complejo Hospitalario Universitario de Santiago /ID# 262723
Santiago de Compostela, Spain
Institut Catala dOncologia - LHospitalet /ID# 262118
L'Hospitalet de Llobregat, Spain
UOMi Cancer Center - Clinica Tres Torres /ID# 262116
Barcelona, Spain
Hospital Universitario Vall de Hebron /ID# 262113
Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 262114
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 262112
Madrid, Spain
Hospital Clinico Universitario de Valencia /ID# 262115
Valencia, Spain
National Cheng Kung University Hospital /ID# 262016
Tainan, Taiwan
Mackay Memorial Hospital /ID# 262534
Taipei, Taiwan
Taipei Medical University Hospital /ID# 262020
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 262535
Taoyuan City, Taiwan
Gazi University Medical Faculty /ID# 261786
Ankara, Turkey (Türkiye)
Ankara City Hospital /ID# 261785
Ankara, Turkey (Türkiye)
Dr. Suat Seren Gogus Has /ID# 261789
Izmir, Turkey (Türkiye)
Trial contact
ABBVIE CALL CENTER
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/28/2026.
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