NCT03260491 : A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Systemic therapy,Treatment | LungLung,Non-Small Cell Lung Cancer

Trial Overview Read MoreRead more

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 MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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, Inc.

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).

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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