A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina-S) in Participants with Non-Small Cell Lung Cancer

Condition studied

Locally advanced or metastatic Non-Small Cell Lung Cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]

Endpoint detail

1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years], 4.Overall Survival (OS) [Time Frame: Approximately 4 years], 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months], 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months], 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months], 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years]