This is a single-arm, open-label phase II investigator-initiated in collaboration with Agenus Biotechnology Company. It will assess the safety and efficacy of the anti-CTLA-4 agent botensilimab in combinstion with anti-PD-1 antybody balstilimab in the frontline treatment of 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 trial received the approval of the Center of Drug and Medical Technology in just 30 working days, followed by the approval of the Ethics Committee of the Ministry of Health within 9 working days.
This trial started in June 2024 and will take until 2030 to complete. It is set to recruite 45 patients. 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
Sponsor: Immune Oncology Research Institute
Collaborators: Agenus Inc.
Principal Investigator: Samvel Bardakhchyan, MD, PhD, Immune Oncology Research Institute
Study Team: Gevorg Tamamyan, MD, MSc, PhD, DSc, Davit Zohrabyan, MD, Liana Safaryan, MD, Amalya Sargsyan, MD, MSc, Elen Baloyan, MD
About IMMONC
Immune Oncology Research Institute (IMMONC) is dedicated to advancing research aimed at preventing, treating, and ultimately curing cancer while making these innovations accessible to those who need them. If you're interested in joining our team, please feel free to contact us at [email protected] or at +374-41 310-048.