Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

[...] ) at the time of informed consent. Histologically documented non-squamous NSCLC that meets all of the following criteria (Note: Subjects with squamous histology were eligible prior to Protocol Version 5.0. After Protocol Version 5.0, subjects with squamous histology are not eligible. Subjects with mixed histology, including those with a squamous component, remain eligible the study even after Protocol Version 5.0): Stage IIIB or IIIC disease and not candidates for surgical [...] , and proto-oncogene1 (ROS1) actionable genomic alterations (AGAs) based on analysis of tumor tissue. If test results for E [...] [...]

Objective Response Rate by Blinded Independent Central ReviewOS in All Randomized Participants, Including Participants WhoWith WereSquamous Administeredand DatoNon-DXdSquamous Histology PFS Based on BICR in CombinationAll Randomized Participants, Including Participants With PembrolizumabSquamous Comparedand WithNon-Squamous PembrolizumabHistology Progression-free Survival by Investigator in Participants Whowith WereNon-Squamous AdministeredHistology, Dato-DXdand inSeparately Combinationfor WithAll PembrolizumabRandomized Compared With PembrolizumabParticipants Progression-free Survival 2 in Pa [...] [...]

Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembroli [...] Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab

[...] ab alone in terms of either Progression Free Survival (PFS) by BICR or Overall Survival (OS) for participants with advanced or metastatic NSCLC with non-squamous histology without actionable genomic alterations whose tumor has high [...]

[...] on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study. Documented negative test results for epidermal growth factor [...] r advanced or metastatic NSCLC. Has received prior treatment for NSCLC with any of the following, including in the adjuvant/neoadj [...] history of (non-infectious) interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumoni [...] imaging at screening. Clinically severe pulmonary compromise, as [...] [...]

[...] umor has high programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who have not previously received systemic ther [...]