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

Sponsor
Immune Oncology Research Institute
Study ID
NCT06322108
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Botensilimab + Balstilimab — DRUG
    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).

Study Details

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.

Key Dates

Start date
Jun 13, 2024
Status verified
Jun 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Botensilimab + Balstilimab
    botensilimab 75 mg IV every 6 weeks (up to 4 doses) + balstilimab 240 mg IV every 2 weeks

Primary Outcome Measure

12-Month Progression-Free Survival (PFS) [ Time Frame: First dose to up to 12 months ]

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