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)

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT06236438

Run by

AbbVie

People needed

840

Starts

2024-04-10

Expected to finish

2031-10-01

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Groupe Sante CHC - Clinique du MontLegia /ID# 262338 — Liège, Liege, Belgium (enrolling)
• Moores Cancer Center /ID# 267782 — La Jolla, California, United States (enrolling)
• Memorial Hospital West /ID# 262221 — Pembroke Pines, Florida, United States (enrolling)
• The University of Chicago Medical Center /ID# 262259 — Chicago, Illinois, United States (enrolling)
• University of Kansas Medical Center /ID# 263196 — Westwood, Kansas, United States (enrolling)
• Bond Clinic /ID# 262611 — Winter Haven, Florida, United States (enrolling)
• Cancer & Hematology Centers of Western Michigan - East /ID# 261826 — Grand Rapids, Michigan, United States (enrolling)
• University Cancer & Blood Cent /ID# 261824 — Athens, Georgia, United States (enrolling)
• Stony Brook Cancer Center /ID# 261954 — Stony Brook, New York, United States (enrolling)
• Cone Health Cancer Center /ID# 262583 — Greensboro, North Carolina, United States (enrolling)
• Oncology Hematology Care, Inc - Blue Ash /ID# 262733 — Cincinnati, Ohio, United States (enrolling)
• Guthrie Robert Packer Hospital /ID# 262758 — Sayre, Pennsylvania, United States (enrolling)
• Baptist Health Lexington /ID# 261823 — Lexington, Kentucky, United States (enrolling)
• Houston Methodist Hospital /ID# 262722 — Houston, Texas, United States (enrolling)
• Texas Oncology - Plano East /ID# 264356 — Plano, Texas, United States (enrolling)
• Texas Oncology - San Antonio Medical Center - Research Drive /ID# 264311 — San Antonio, Texas, United States (enrolling)
• Washington University-School of Medicine /ID# 262759 — St Louis, Missouri, United States (enrolling)
• Vista Oncology - East Olympia /ID# 262303 — Olympia, Washington, United States (enrolling)
• Canberra Hospital /ID# 261891 — Garran, Australian Capital Territory, Australia (enrolling)
• Nepean Hospital /ID# 262157 — Kingswood, New South Wales, Australia (enrolling)
• Westmead Hospital /ID# 261894 — Westmead, New South Wales, Australia (enrolling)
• Universitair Ziekenhuis Antwerpen /ID# 261270 — Edegem, Antwerpen, Belgium (enrolling)
• Cliniques Universitaires UCL Saint-Luc /ID# 261267 — Brussels, Brussels Capital, Belgium (enrolling)
• Hospital La Louviere Site Jolimont - Helora /ID# 261269 — La Louvière, Hainaut, Belgium (enrolling)
• AZ Maria Middelares /ID# 262313 — Ghent, Belgium (enrolling)

Full record on ClinicalTrials.gov

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