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) - Trial NCT06236438
Access comprehensive clinical trial information for NCT06236438 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by AbbVie and is currently Recruiting. The study focuses on Non-Small Cell Lung Cancer. Target enrollment is 840 participants.
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Study Focus
Sponsor & Location
AbbVie
Timeline & Enrollment
Phase 2/3
Apr 19, 2024
Oct 08, 2031
Primary Outcome
Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR),Stage 2: Overall Survival (OS)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06236438
Non-Device Trial