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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 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
Pemetrexed
2014
Completed Phase 3
~5550
Budigalimab
2021
Completed Phase 1
~170
Carboplatin
2014
Completed Phase 3
~6120
Pembrolizumab
2017
Completed Phase 3
~2810
Cisplatin
2013
Completed Phase 3
~3120

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Who is running the clinical trial?

AbbVieLead Sponsor
1,017 Previous Clinical Trials
518,869 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
441 Previous Clinical Trials
159,504 Total Patients Enrolled
~560 spots leftby Oct 2031
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