RecruitingPhase 2NCT06322108

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

Enrollment

45 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — balstilimab and botensilimab — as a first treatment for people with advanced non-small cell lung cancer (NSCLC) that has spread to other parts of the body. These drugs help the immune system find and attack cancer cells. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with metastatic non-small cell lung cancer and have not yet received treatment for metastatic disease - Your tumor does not have EGFR mutations or ALK rearrangements (specific genetic changes) - Your physical performance (ECOG score) is 0 or 1 - Your life expectancy is at least 3 months - Your cancer shows measurable disease on scans - Your liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if:** - You have EGFR mutations or ALK rearrangements (other targeted therapies may be more appropriate) - You have already received treatment for metastatic disease - You have severe autoimmune disease or are on immune-suppressing medications - Your prior treatment relapse occurred within 6 months of finishing neoadjuvant or adjuvant therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBotensilimab + 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).


Locations(1)

Hematology Center named after prof. R. Yeolyan

Yerevan, Armenia

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NCT06322108


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