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)
Public ClinicalTrials.gov record NCT06236438. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06236438
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 167 participants
Conditions and interventions
Conditions
Interventions
- Livmoniplimab Drug
- Budigalimab Drug
- Pembrolizumab Drug
- Pemetrexed Drug
- Cisplatin Drug
- Carboplatin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 10, 2024 (Actual)
- Primary completion
- Oct 2031 (Estimated)
- Completion
- Oct 2031 (Estimated)
- Last update posted
- Oct 19, 2026
2024 – 2031
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC San Diego Health - Moores Cancer Center /ID# 267782 | La Jolla | California | 92037 | — |
| Memorial Hospital West /ID# 262221 | Pembroke Pines | Florida | 33028 | — |
| Bond Clinic /ID# 262611 | Winter Haven | Florida | 33880 | — |
| University Cancer and Blood Cent /ID# 261824 | Athens | Georgia | 30607 | — |
| The University of Chicago Medical Center /ID# 262259 | Chicago | Illinois | 60637-1443 | — |
| University of Kansas Medical Center /ID# 263196 | Westwood | Kansas | 66205 | — |
| Baptist Health Lexington /ID# 261823 | Lexington | Kentucky | 40503 | — |
| Cancer & Hematology Centers of Western Michigan - East /ID# 261826 | Grand Rapids | Michigan | 49546-7062 | — |
| 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 | — |
| Cone Health Cancer Center /ID# 262583 | Greensboro | North Carolina | 27403-1109 | — |
| Oncology Hematology Care, Inc - Blue Ash /ID# 262733 | Cincinnati | Ohio | 45252 | — |
| Guthrie Robert Packer Hospital /ID# 262758 | Sayre | Pennsylvania | 18840 | — |
| Renovatio clinical /ID# 262000 | El Paso | Texas | 79915-1803 | — |
| Houston Methodist Hospital /ID# 262722 | Houston | Texas | 77030 | — |
| Texas Oncology - Plano East /ID# 264356 | Plano | Texas | 75075 | — |
| Texas Oncology - San Antonio Medical Center - Research Drive /ID# 264311 | San Antonio | Texas | 78240 | — |
| Renovatio Clinical /ID# 261999 | The Woodlands | Texas | 77380-3181 | — |
| Vista Oncology - East Olympia /ID# 262303 | Olympia | Washington | 98506-5028 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06236438, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06236438 live on ClinicalTrials.gov.