← Back to Search

Checkpoint Inhibitor

Livmoniplimab + Budigalimab + Chemotherapy for Lung Cancer (LIVIGNO-4 Trial)

Phase 2 & 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 55 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial is looking at a new drug called livmoniplimab, in combination with other drugs and chemotherapy, to treat non-squamous non-small cell lung cancer. The study will involve around

Who is the study for?

Adults with untreated metastatic non-squamous NSCLC, who have at least one measurable lesion and no EGFR or ALK mutations. Participants should not have other genomic abnormalities treatable by approved therapies, must expect to live at least 3 more months, and need proper organ function.

What is being tested?

The trial is testing Livmoniplimab combined with Budigalimab plus chemotherapy against Pembrolizumab with chemotherapy in two stages. Stage 1 has four groups receiving various treatments; Stage 2 has two groups based on the optimized dose from Stage 1.

What are the potential side effects?

Potential side effects include reactions related to IV infusion, impact on organ functions due to drug toxicity, fatigue from treatment burden, possible blood-related issues from chemotherapy, and general discomfort from frequent medical assessments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 55 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 55 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 55 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)

Stage 2: Overall Survival (OS)

Secondary study objectives

Stage 1: BOR of CR/PR per Investigator

Stage 1: Duration of Response (DOR)

Stage 1: OS

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Stage 2 (Arm 2): PlaceboExperimental Treatment4 Interventions

Participants will receive placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.

Group II: Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)Experimental Treatment5 Interventions

Participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.

Group III: Stage 1 (Cohort 4): PembrolizumabExperimental Treatment4 Interventions

Participants will receive pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.

Group IV: Stage 1 (Cohort 3): BudigalimabExperimental Treatment4 Interventions

Participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed.

Group V: Stage 1 (Cohort 2): Livmoniplimab Dose BExperimental Treatment5 Interventions

Participants will receive livmoniplimab (dose B) + budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.

Group VI: Stage 1 (Cohort 1): Livmoniplimab Dose AExperimental Treatment5 Interventions

Participants will receive livmoniplimab (dose A)+ budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug