Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Status:
Recruiting
Trial end date:
2025-11-12
Target enrollment:
Participant gender:
Summary
This study aims to evaluate the efficacy and safety of DS-1062a in participants with
metastatic, unresectable NSCLC having progressed on one, but not more than three previous
standard therapies. Moreover, the immune effects, the predictors of resistance and response
to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will
be assessed and will help identify the subgroups that will mostly benefit from the treatment.
The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated.
A total of 100 participants are planned to be included in the study. Participants will
receive, every three weeks, a dose of DS-1062a equivalent to 6 mg/kg of body weight until
progression or until unacceptable toxicity.
Tumor evaluation will be performed every six weeks by the mean of a computed tomography for
the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain
and/or bone CT scans will be also performed throughout the study for participants with brain
and/or bone metastasis.
The safety of the product will be assessed at each cycle, through complete clinical exams,
biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the
collection of ongoing toxicities or adverse events.