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)

Purpose

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.

Condition

  • Non-Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Stage 1 (Cohort 1): Livmoniplimab Dose A 		Participants will receive livmoniplimab (dose A)+ budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.
  • Drug: Livmoniplimab
    Intravenously (IV) Infusion
    Other names:
    • ABBV-151
  • Drug: Budigalimab
    IV Infusion
    Other names:
    • ABBV-181
  • Drug: Pemetrexed
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Carboplatin
    IV Injection
  • Drug: Carboplatin
    IV Infusion
Experimental
Stage 1 (Cohort 2): Livmoniplimab Dose B 		Participants will receive livmoniplimab (dose B) + budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.
  • Drug: Livmoniplimab
    Intravenously (IV) Infusion
    Other names:
    • ABBV-151
  • Drug: Budigalimab
    IV Infusion
    Other names:
    • ABBV-181
  • Drug: Pemetrexed
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Carboplatin
    IV Injection
  • Drug: Carboplatin
    IV Infusion
Experimental
Stage 1 (Cohort 3): Budigalimab 		Participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed.
  • Drug: Budigalimab
    IV Infusion
    Other names:
    • ABBV-181
  • Drug: Pemetrexed
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Carboplatin
    IV Injection
  • Drug: Carboplatin
    IV Infusion
Experimental
Stage 1 (Cohort 4): Pembrolizumab 		Participants will receive pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.
  • Drug: Pembrolizumab
    IV Infusion
  • Drug: Pemetrexed
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Carboplatin
    IV Injection
  • Drug: Carboplatin
    IV Infusion
Experimental
Stage 2 (Arm 1): Livmoniplimab (Dose Optimized) 		Participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed.
  • Drug: Livmoniplimab
    Intravenously (IV) Infusion
    Other names:
    • ABBV-151
  • Drug: Budigalimab
    IV Infusion
    Other names:
    • ABBV-181
  • Drug: Pemetrexed
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Carboplatin
    IV Injection
  • Drug: Carboplatin
    IV Infusion
Experimental
Stage 2 (Arm 2): Placebo 		Participants will receive placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed.
  • Drug: Pembrolizumab
    IV Infusion
  • Drug: Pemetrexed
    IV Infusion
  • Drug: Cisplatin
    IV Infusion
  • Drug: Carboplatin
    IV Injection
  • Drug: Carboplatin
    IV Infusion

Recruiting Locations

University of Kansas Medical Center /ID# 263196
Westwood, Kansas 66205

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com