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

Non-small Cell Lung Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT06322108
• Study type: Interventional
• Source: Immune Oncology Research Institute
• Contact: Samvel Bardakhchyan, MD, PhD
• Phone: +374 (010) 283800
• Email: samvelbardakhchyan@gmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2024
• Completion date: April 2030