Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer
brief summary
This is a phase 3, open-label, 4-cohort study (3 randomized cohorts and 1 single-arm cohort). Participants enrolled in each cohort will be treated as detailed below. Each study cohort will be analyzed separately. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the investigator feels that it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months after the first dose of study drug.
detailed description
The protocol divides patients into 4 cohorts (A, B, C and D), with varying prior treatments, histology of cancer, PD-L1 expression status to best compare and match appropriate treatments for those subsets of patients. This study is being performed to determine if adding NAI in the first line treatment setting of advanced non-small cell lung cancer has the potential to enhance outcomes across varying treatment backbones.
official title
Phase 3, Open-Label, 4-Cohort Study of Nogapendekin Alfa Inbakicept in Combination With Current Standard of Care as First-Line Treatment for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer