NCT06322108

Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Immune Oncology Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to see if the combination of immunotherapy agents botensilimab and balstilimab is safe and effective in participants with metastatic non-small cell lung cancer (NSCLC) as a first-line treatment.

Detailed description

This is a single-arm, open-label phase II study to evaluate the safety and efficacy of the combination of botensilimab and balstilimab in participants with metastatic non-small cell lung cancer (NSCLC). The study will enroll participants with a histologically confirmed diagnosis of metastatic NSCLC and without targetable EGFR mutation or ALK rearrangement, while excluding those with untreated brain metastases or oligometastatic disease lacking targetable lesions. The total estimated maximum time of study participation for each patient is approximately 49 months across 3 periods: * Screening Period: approximately 28 days * Treatment Period: up to 24 months, or until any criterion for stopping the study drug or withdrawal from the study occurs * Follow-up Period: up to 24 months from last dose of study treatment for every patient who is alive Study Duration * Recruitment: 2 years * Treatment: 2 years * Follow-up: 2 years

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Botensilimab + Balstilimab	Botensilimab is a fragment crystallizable (Fc)-engineered human immunoglobulin G1 (IgG1) monoclonal antibody that targets cytotoxic T lymphocyte-associated protein 4 (CTLA-4). Balstilimab is a human monoclonal antibody that targets programmed cell death protein 1 (PD-1).

Timeline

• Start date: 2024-06-13
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2024-03-20
• Last updated: 2025-05-08

Locations

1 site across 1 country: Armenia

Regulatory

• FDA-regulated drug study