← Back to Search

Checkpoint Inhibitor

Stage 1 (Cohort 4): Pembrolizumab for Non-Small Cell 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

LIVIGNO-4 Trial 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.Check my eligibility

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.See study design

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.

LIVIGNO-4 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Stage 2: Overall Survival (OS)

Secondary outcome measures

Stage 1: BOR of CR/PR per Investigator

Stage 1: Duration of Response (DOR)

Stage 1: OS

+9 more

LIVIGNO-4 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

Cisplatin

2013

Completed Phase 3

~1940

Pembrolizumab

2017

Completed Phase 2

~2010

Budigalimab

2021

Completed Phase 1

~170

Pemetrexed

2014

Completed Phase 3

~5250

Carboplatin

2014

Completed Phase 3

~6670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

501,550 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,269 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being sought for enrollment in this medical study?

"According to details on clinicaltrials.gov, this trial is currently in the process of actively seeking eligible participants. Initially shared on April 19th, 2024, it underwent its latest update on March 20th of the same year."

Answered by AI

What is the current number of individuals being recruited for participation in this research study?

"Indeed, details on clinicaltrials.gov highlight the ongoing recruitment efforts for this particular clinical trial. The study was initially posted on April 19th, 2024 and most recently updated on March 20th, 2024. Recruitment is aimed at enrolling a total of 840 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2024. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236438.

All > Paid Studies Seattle > Vancouver