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)

Launched by ABBVIE · Jan 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with untreated metastatic non-squamous non-small cell lung cancer (NSCLC), which is a serious type of lung cancer. Researchers want to compare the effectiveness and safety of an investigational drug called livmoniplimab, combined with another drug called budigalimab and chemotherapy, against a standard treatment that includes pembrolizumab and chemotherapy. The trial has two stages: the first stage tests different doses and combinations of these treatments, while the second stage focuses on the best dose of livmoniplimab alongside budigalimab and chemotherapy.

To be eligible for this trial, participants need to have a confirmed diagnosis of metastatic non-squamous NSCLC without certain genetic mutations that would make them eligible for other targeted therapies. They should have at least one measurable tumor and a life expectancy of at least three months. Participants can expect to attend regular visits for treatment and monitoring over the study's duration, which is about 55 months. While this trial may involve more frequent assessments and treatments compared to standard care, it offers the potential to contribute to new options for lung cancer treatment.

Gender

ALL

Eligibility criteria

• 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.