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NCT Number: NCT06236438

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)

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Canberra Hospital /ID# 261891, Garran, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Received prior systemic therapy for the treatment of metastatic NSCLC.

Treatment and study plan

Livmoniplimab

Drug

Intravenously (IV) Infusion

Other names: ABBV-151

Budigalimab

Drug

IV Infusion

Other names: ABBV-181

Pembrolizumab

Drug

IV Infusion

Pemetrexed

Drug

IV Infusion

Cisplatin

Drug

IV Infusion

carboplatin

Drug

IV Injection

Primary outcomes

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

    Time frame: 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.

  2. Stage 2: Overall Survival (OS)

    Time frame: Up to 55 Months

    OS is defined as the time measured from randomization until death from any cause.

Secondary outcomes

  1. Stage 1: Progression Free Survival (PFS)

    Time frame: 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.

  2. Stage 1: Duration of Response (DOR)

    Time frame: 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.

  3. Stage 1: OS

    Time frame: Up to 21 Months

    OS is defined as the time measured from randomization until death from any cause.

  4. Stage 2: PFS

    Time frame: 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.

  5. Stage 2: BOR of CR/PR

    Time frame: 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.

  6. 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)

    Time frame: 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).

  7. Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

    Time frame: 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.

  8. 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

    Time frame: 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).

  9. Stage 2: PFS per Investigator

    Time frame: 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.

  10. Stage 1: BOR of CR/PR per Investigator

    Time frame: 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.

  11. Stage 2: DOR

    Time frame: 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.

  12. Stage 2: DOR per investigator

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: LIVIGNO-4

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Feb 1, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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