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)
Lung Cancer
Unknown Primary
18 Years and older, Male and Female
M23-721 (primary)
NCI-2024-06526
2023-505773-32-00
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.
Eligibility
- 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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.