Duke University Health System | Duke Gastroenterology Clinic - Clinic 2
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
Full description
The primary objective of this study is to assess whether treatment with I-DXd improves objective response rate (ORR) and prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy/safety of I-DXd, health economics and outcome research measures (including patient reported outcomes), immunogenicity of I-DXd, B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Participants must meet all the following criteria to be eligible for randomization into the study:
Exclusion Criteria
Participants who meet any of the following criteria will be disqualified from entering the study:
Primary purpose
Allocation
Interventional model
Masking
468 participants in 2 patient groups
Loading...
Central trial contact
Daiichi Sankyo Contact for Clinical Trial Information
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal