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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)
Timepoint [1] 0 0
Up to 21 Months
Primary outcome [2] 0 0
Stage 2: Overall Survival (OS)
Timepoint [2] 0 0
Up to 55 Months
Secondary outcome [1] 0 0
Stage 1: Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to 21 Months
Secondary outcome [2] 0 0
Stage 1: Duration of Response (DOR)
Timepoint [2] 0 0
Up to 21 Months
Secondary outcome [3] 0 0
Stage 1: OS
Timepoint [3] 0 0
Up to 21 Months
Secondary outcome [4] 0 0
Stage 2: PFS
Timepoint [4] 0 0
Up to 55 Months
Secondary outcome [5] 0 0
Stage 2: BOR of CR/PR
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)
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)
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
Timepoint [8] 0 0
Up to 55 Months
Secondary outcome [9] 0 0
Stage 2: PFS per Investigator
Timepoint [9] 0 0
Up to 55 Months
Secondary outcome [10] 0 0
Stage 1: BOR of CR/PR per Investigator
Timepoint [10] 0 0
Up to 21 Months
Secondary outcome [11] 0 0
Stage 2: DOR
Timepoint [11] 0 0
Up to 55 Months
Secondary outcome [12] 0 0
Stage 2: DOR per investigator
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
8/10/2031
Actual
Sample size
Target
840
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Nepean Hospital /ID# 262157 - Kingswood
Recruitment hospital [2] 0 0
Westmead Hospital /ID# 261894 - Westmead
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 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
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Israel
State/province [8] 0 0
H_efa
Country [9] 0 0
Israel
State/province [9] 0 0
Yerushalayim
Country [10] 0 0
Japan
State/province [10] 0 0
Saitama
Country [11] 0 0
Japan
State/province [11] 0 0
Tokyo
Country [12] 0 0
Taiwan
State/province [12] 0 0
Keelung
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taipei City
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taoyuan City

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


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