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Not recruiting
Phase 2
Phase 3

Livmoniplimab & Budigalimab

Sponsor:

AbbVie

Code:

NCT06236438

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Livmoniplimab

Budigalimab

Pembrolizumab

Pemetrexed

Cisplatin

Study Details

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT06236438

Start date

Apr 10, 2024

Status verified date

Oct, 2026

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

167 participants

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Livmoniplimab

Intravenously (IV) Infusion

Budigalimab

IV Infusion

Pembrolizumab

IV Infusion

Pemetrexed

IV Infusion

Cisplatin

IV Infusion

Carboplatin

IV Injection

Carboplatin

IV Infusion

Primary outcome measure

  • Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) [ Time Frame: Up to 21 Months ]
  • Stage 2: Overall Survival (OS) [ Time Frame: Up to 55 Months ]

Central Contacts and Locations

More Information

Sponsor

AbbVie

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Non-Small Cell Lung Cancer
  • Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
  • NSCLC
  • Livmoniplimab
  • Budigalimab
  • Pembrolizumab
  • Chemotherapy
  • ABBV-181
  • ABBV-151

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.