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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: Recruiting Phase 2 study of Non-Small Cell Lung Cancer, sponsored by AbbVie.

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 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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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 +

Primary Outcome

BOR of CR/PR is defined as achieving CR or PR according to response evaluation criteria in solid tumors (RECIST) v1.1 as determined by investigators at any time prior to subsequent anticancer therapy. Objective response rate (ORR), defined as the percentage of participants with a BOR of CR/PR, will be summarized.

Conditions Studied

Non-Small Cell Lung Cancer

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

FieldValue
Enrollment Target 840 participants
Start Date 2024-04-10
Est. Completion 2031-10
Phase Phase 2
AbbVie

526 total trials

What NCT06236438 shows while recruiting

NCT06236438 is an interventional study that assigns participants to a tested intervention. The registered 840 participants enrollment target is mid-sized for trials with a published cap, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (29% higher).

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 names 20 study sites across 15 states, led by 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.

Where NCT06236438's enrollment target sits among peer trials

840 33rd of 454 higher than 422 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06236438

Source: ClinicalTrials.gov NCT06236438, the US trial registry maintained by the National Library of Medicine. NCT06236438 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.