Home › Trials › NCT06236438

Evaluating a new treatment for metastatic non-squamous non-small cell lung cancer

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)

Phase2; Phase3 Interventional AbbVie · NCT06236438

This study is testing a new treatment combining livmoniplimab, budigalimab, and chemotherapy to see if it works better than pembrolizumab plus chemotherapy for adults with untreated metastatic non-squamous non-small cell lung cancer.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment840 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionslivmoniplimab, budigalimab, pembrolizumab, chemotherapy
Locations61 sites (La Jolla, California and 60 other locations)
Trial IDNCT06236438 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, optimal dosing, and effectiveness of livmoniplimab combined with budigalimab and chemotherapy compared to pembrolizumab plus chemotherapy in adults with untreated metastatic non-squamous non-small cell lung cancer (NSCLC). The trial consists of two stages, with Stage 1 involving multiple treatment arms to determine the best combination and dosage. Participants will be monitored for adverse events and changes in disease activity throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults with untreated metastatic non-squamous non-small cell lung cancer who have not received prior systemic therapy.

Not a fit: Patients with known EGFR or ALK mutations or those who have previously received systemic therapy for metastatic NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with metastatic non-squamous non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

\- Received prior systemic therapy for the treatment of metastatic NSCLC.

Where this trial is running

La Jolla, California and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung CancerUntreated Metastatic Non-Squamous Non-Small Cell Lung CancerNSCLCLivmoniplimabBudigalimabPembrolizumabChemotherapyABBV-181
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.