Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06236438 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 840
- Enrollment target
- 20
- Study locations
NCT06236438 is a Phase 2 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by AbbVie. The registered enrollment target is 840 participants, above the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT06236438, a Phase 2 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 840 participants
- Enrollment target
- 20
- Study locations
Study 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 +
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Budigalimab
- DRUG Livmoniplimab
Study Locations (20)
Texas
- Renovatio clinical /ID# 262000 - El Paso
- Houston Methodist Hospital /ID# 262722 - Houston
- Texas Oncology - Plano East /ID# 264356 - Plano
- Texas Oncology - San Antonio Medical Center - Research Drive /ID# 264311 - San Antonio
- Renovatio Clinical /ID# 261999 - The Woodlands
Florida
- Memorial Hospital West /ID# 262221 - Pembroke Pines
- Bond Clinic /ID# 262611 - Winter Haven
California
- Moores Cancer Center /ID# 267782 - La Jolla
Georgia
- University Cancer & Blood Cent /ID# 261824 - Athens
Illinois
- The University of Chicago Medical Center /ID# 262259 - Chicago
Kansas
- University of Kansas Medical Center /ID# 263196 - Westwood
Kentucky
- Baptist Health Lexington /ID# 261823 - Lexington
Michigan
- Cancer & Hematology Centers of Western Michigan - East /ID# 261826 - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 840 participants |
| Start Date | 2024-04-10 |
| Est. Completion | 2031-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06236438
The ClinicalTrials.gov registry entry for NCT06236438 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 840 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (28% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06236438 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Texas, Florida, California.
Frequently Asked Questions
What is clinical trial NCT06236438 about?
NCT06236438 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT06236438?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 840 participants. The study started on 2024-04-10. Estimated completion is 2031-10.
What conditions does trial NCT06236438 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06236438?
The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Budigalimab (DRUG), Livmoniplimab (DRUG).
Who is sponsoring clinical trial NCT06236438?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06236438 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
RECRUITING · Phase 2
-
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
RECRUITING · Phase 2
-
Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)
RECRUITING · Phase 2
-
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
RECRUITING · Phase 2
-
A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)
RECRUITING · Phase 2
-
Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.