This phase I trial is trying to understand how safe and well tolerated a new targeted therapy drug is in patients with non-small cell lung cancer that has spread to other parts of the body.
This trial is treating patients with non-small cell lung cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
- You have previously been treated (or are currently being treated) on a clinical trial.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer
Commercial Sponsor
Daiichi Sankyo Ltd.
Summary
This trial will be conducted over two parts: dose escalation and dose expansion. Eligible patients will be assigned based on their disease and treatment characteristics. Dose escalation will commence with patients receiving U3-1402 intravenously (IV) once every three weeks at 3.2 mg/kg. This will be increased to 6.4mg/kg, 9.6mg/kg and 12.8mg/kg across four cohorts. In the dose expansion phase, patients with non-small cell lung cancer will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE).
Not Recruiting Hospitals Read More