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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06236438




Registration number
NCT06236438
Ethics application status
Date submitted
24/01/2024
Date registered
1/02/2024

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2023-505773-32-00
Secondary ID [2] 0 0
M23-721
Universal Trial Number (UTN)
Trial acronym
LIVIGNO-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Livmoniplimab
Treatment: Drugs - Budigalimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Carboplatin

Experimental: Stage 1 (Cohort 1): Livmoniplimab Dose A - Participants will receive livmoniplimab (dose A)+ budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.

Experimental: Stage 1 (Cohort 2): Livmoniplimab Dose B - Participants will receive livmoniplimab (dose B) + budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.

Experimental: Stage 1 (Cohort 3): Budigalimab - Participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed.

Experimental: Stage 1 (Cohort 4): Pembrolizumab - Participants will receive pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.

Experimental: Stage 2 (Arm 1): Livmoniplimab (Dose Optimized) - Participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.

Experimental: Stage 2 (Arm 2): Placebo - Participants will receive placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.


Treatment: Drugs: Livmoniplimab
Intravenously (IV) Infusion

Treatment: Drugs: Budigalimab
IV Infusion

Treatment: Drugs: Pembrolizumab
IV Infusion

Treatment: Drugs: Pemetrexed
IV Infusion

Treatment: Drugs: Cisplatin
IV Infusion

Treatment: Drugs: Carboplatin
IV Injection

Treatment: Drugs: Carboplatin
IV Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to 21 Months
Primary outcome [2] 0 0
Stage 2: Overall Survival (OS)
Assessment method [2] 0 0
OS is defined as the time measured from randomization until death from any cause.
Timepoint [2] 0 0
Up to 55 Months
Secondary outcome [1] 0 0
Stage 1: Progression Free Survival (PFS)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to 21 Months
Secondary outcome [2] 0 0
Stage 1: Duration of Response (DOR)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Up to 21 Months
Secondary outcome [3] 0 0
Stage 1: OS
Assessment method [3] 0 0
OS is defined as the time measured from randomization until death from any cause.
Timepoint [3] 0 0
Up to 21 Months
Secondary outcome [4] 0 0
Stage 2: PFS
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Up to 55 Months
Secondary outcome [5] 0 0
Stage 2: BOR of CR/PR
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Up to 55 Months
Secondary outcome [6] 0 0
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)
Assessment method [6] 0 0
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).
Timepoint [6] 0 0
Up to 55 Months
Secondary outcome [7] 0 0
Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Assessment method [7] 0 0
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 \ at All" to 4 "Very severe \" or from 0 "Never" to 4 "Always," depending on the item's format.
Timepoint [7] 0 0
Up to 55 Months
Secondary outcome [8] 0 0
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
Assessment method [8] 0 0
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).
Timepoint [8] 0 0
Up to 55 Months
Secondary outcome [9] 0 0
Stage 2: PFS per Investigator
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Up to 55 Months
Secondary outcome [10] 0 0
Stage 1: BOR of CR/PR per Investigator
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
Up to 21 Months
Secondary outcome [11] 0 0
Stage 2: DOR
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
Up to 55 Months
Secondary outcome [12] 0 0
Stage 2: DOR per investigator
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
Up to 55 Months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Received prior systemic therapy for the treatment of metastatic NSCLC.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2031
Actual
Sample size
Target
840
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 0 0
The Canberra Hospital /ID# 261891 - Garran
Recruitment hospital [2] 0 0
Nepean Hospital /ID# 262157 - Kingswood
Recruitment hospital [3] 0 0
Westmead Hospital /ID# 261894 - Westmead
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Chile
State/province [13] 0 0
Araucania
Country [14] 0 0
Chile
State/province [14] 0 0
Region Metropolitana Santiago
Country [15] 0 0
Israel
State/province [15] 0 0
H_efa
Country [16] 0 0
Israel
State/province [16] 0 0
Yerushalayim
Country [17] 0 0
Japan
State/province [17] 0 0
Chiba
Country [18] 0 0
Japan
State/province [18] 0 0
Saitama
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
Puerto Rico
State/province [20] 0 0
Rio Piedras
Country [21] 0 0
Taiwan
State/province [21] 0 0
Tainan
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei City
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taoyuan City
Country [24] 0 0
Turkey
State/province [24] 0 0
Ankara

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06236438