Brief Summary
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.
All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
Intervention / Treatment
- Biological: Sacituzumab tirumotecan
- Biological: Pembrolizumab
Inclusion Criteria
- Histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of squamous or nonsquamous NSCLC
- Confirmation that epidermal growth factor receptor- (EGFR-), anaplastica term used to describe abnormal cancer cells that grow uncontrollably in the body and have little or no resemblence to regular cells lymphomacancers of the lymphatic system kinase- (ALK-), or proto-oncogenea type of gene that normally regulates cell growth and division, but when mutated can cause uncontrollable cell growth and may lead to cancer tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
- Provided tumor tissuea group of cells that work together to perform a function that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cellsthe basic structural and functional unit of all living things as assessed by an immunohistochemistry (IHC) central laboratory
- An Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
- A life expectancy of at least 3 months.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)