A Study of Sigvotatug Vedotin Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer (Be6A Lung-01).
Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Abughanimeh, Omar
Contact Information:
Kimberly Shields
kimberly.shields@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06012435?term=NCT06012435&rank=1#participation-criteria
Summary
Primary
To compare the OS between the experimental (SGN-B6A) and control (docetaxel) arms
To compare the ORR as assessed by blinded independent central review (BICR) between the experimental and control arms
Key Secondary
To compare PFS as assessed by BICR between the experimental and control arms
Other Secondary
To compare the ORR as assessed by investigator between the experimental and control arms
To compare PFS as assessed by investigator between the experimental and control arms
To estimate the DOR for the experimental and control arms
To characterize the safety and tolerability profile of SGN-B6A
To compare change in quality of life (QoL), functioning, and lung cancer symptom response between the experimental and control arms
To compare time to deterioration (TTD) in QoL, functioning, and lung cancer symptoms between the experimental and control arms
Exploratory
To compare the disease control rate (DCR) between the experimental and control arms
To estimate time-to-response for the experimental and control arms
To characterize the PK of SGN-B6A
To explore the relationship between SGN-B6A PK and selected efficacy, safety, and/or other relevant exploratory endpoints as deemed appropriate
To characterize the immunogenicity of SGN-B6A
To compare the impact on patient-reported outcomes (PROs) between the experimental and control arms
To characterize the pharmacodynamic activity, response, and resistance markers of SGN-B6A