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)
- 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 + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
- Acronym
- LIVIGNO-4
- Short title
- 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)
- Official title
- 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)
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2/Phase 3
- Study type
- Interventional
- Completion date
- 2031-10-01
- First posted
- 2024-02-01
- Registry last updated
- 2026-08-28
- Primary completion date
- 2031-10-01
- Start date
- 2024-04-10
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AbbVie
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06236438
- ClinicalTrials.gov ID
- NCT06236438
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
Timeframe: Up to 21 Months
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.
Stage 2: Overall Survival (OS)
Timeframe: Up to 55 Months
OS is defined as the time measured from randomization until death from any cause.
Stage 1: Progression Free Survival (PFS)
Timeframe: Up to 21 Months
PFS is defined as the time measured from randomization until the first documentation of progressive disease (PD) according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.
Stage 1: Duration of Response (DOR)
Timeframe: Up to 21 Months
DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.
Stage 1: OS
Timeframe: Up to 21 Months
OS is defined as the time measured from randomization until death from any cause.
Stage 2: PFS
Timeframe: Up to 55 Months
PFS is defined as the time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.
Stage 2: BOR of CR/PR
Timeframe: Up to 55 Months
BOR of CR/PR is defined as achieving CR or PR according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy. ORR, defined as the percentage of participants with a BOR of CR/PR, will be summarized.
Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17)
Timeframe: Up to 55 Months
The EORTC QLQ-F17, a shorter, 17-item version that includes only the functional scales and the Global Health Status / Quality of Life scale of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Participants rate items on a 4 point scale ranging form 1 to 4 (1- Not at All, 2= A Little, 3 = Quite a Bit, and 4= Very Much).
Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Timeframe: Up to 55 Months
The NSCLC -SAQ scale with seven items assessing 5 symptoms of NSCLC (cough, pain, dyspnea, fatigue and poor appetites). The recall period is "over the last 7 days." Each item has a 5-point verbal rating scale from either 0 "No \<symptom\> at All" to 4 "Very severe \<symptom\>" or from 0 "Never" to 4 "Always," depending on the item's format.
Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17
Timeframe: Up to 55 Months
The EORTC QLQ-F17, a shorter, 17-item version that includes only the functional scales and the Global Health Status / Quality of Life scale of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Participants rate items on a 4 point scale ranging form 1 to 4 (1- Not at All, 2= A Little, 3 = Quite a Bit, and 4= Very Much).
Stage 2: PFS per Investigator
Timeframe: Up to 55 Months
PFS is defined as the time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by the investigator or death from any cause, whichever occurs first.
Stage 1: BOR of CR/PR per Investigator
Timeframe: Up to 21 Months
BOR of CR/PR is defined as achieving CR or PR according to RECIST 1.1 as determined by investigators. ORR, defined as the percentage of participants with a BOR of CR/PR, will be summarized.
Stage 2: DOR
Timeframe: Up to 55 Months
DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by BICR or death from any cause, whichever occurs first.
Stage 2: DOR per investigator
Timeframe: Up to 55 Months
DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- Received prior systemic therapy for the treatment of metastatic NSCLC.
- UC San Diego Health - Moores Cancer Center /ID# 267782La Jolla, United StatesRecruiting
- Memorial Hospital West /ID# 262221Pembroke Pines, United StatesCompleted
- Bond Clinic /ID# 262611Winter Haven, United StatesRecruiting
- University Cancer and Blood Cent /ID# 261824Athens, United StatesRecruiting
- The University of Chicago Medical Center /ID# 262259Chicago, United StatesRecruiting
- University of Kansas Medical Center /ID# 263196Westwood, United StatesRecruiting
- Baptist Health Lexington /ID# 261823Lexington, United StatesRecruiting
- Cancer & Hematology Centers of Western Michigan - East /ID# 261826Grand Rapids, United StatesRecruiting
- Washington University-School of Medicine /ID# 262759St Louis, United StatesRecruiting
- Stony Brook Cancer Center /ID# 261954Stony Brook, United StatesCompleted
- Cone Health Cancer Center /ID# 262583Greensboro, United StatesRecruiting
- Oncology Hematology Care, Inc - Blue Ash /ID# 262733Cincinnati, United StatesRecruiting
- Guthrie Robert Packer Hospital /ID# 262758Sayre, United StatesRecruiting
- Renovatio clinical /ID# 262000El Paso, United StatesCompleted
- Houston Methodist Hospital /ID# 262722Houston, United StatesRecruiting
- Texas Oncology - Plano East /ID# 264356Plano, United StatesRecruiting
- Texas Oncology - San Antonio Medical Center - Research Drive /ID# 264311San Antonio, United StatesRecruiting
- Renovatio Clinical /ID# 261999The Woodlands, United StatesCompleted
- Vista Oncology - East Olympia /ID# 262303Olympia, United StatesRecruiting
- Canberra Hospital /ID# 261891Garran, AustraliaRecruiting
- Nepean Hospital /ID# 262157Kingswood, AustraliaRecruiting
- Westmead Hospital /ID# 261894Westmead, AustraliaRecruiting
- Universitair Ziekenhuis Antwerpen /ID# 261270Edegem, BelgiumRecruiting
- Cliniques Universitaires UCL Saint-Luc /ID# 261267Brussels, BelgiumRecruiting
- Hospital La Louviere Site Jolimont - Helora /ID# 261269La Louvière, BelgiumRecruiting
And 36 more, listed on the interactive page.
- 2023
- 2023-505773-32-00
Related records
Drugs (6)
Lead sponsors (1)
Conditions (1)
- Non-small cell lung carcinoma Primary condition