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A phase II trial in platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line chemotherapy.

Trial Profile

A phase II trial in platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line chemotherapy.

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 20 Jan 2020

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At a glance

  • Drugs Docetaxel (Primary)
  • Indications Small cell lung cancer
  • Focus Therapeutic Use
  • Sponsors Plus Therapeutics

Most Recent Events

  • 16 Jul 2019 According to a Cytori Therapeutics media release, the company intends to submit a Phase 2 clinical trial protocol in Small Cell Lung Cancer patients to the U.S. FDA in the second half of 2019.
  • 03 Jul 2019 New trial record
  • 01 Jul 2019 According to a Cytori Therapeutics media release, feedback from the FDA included that a 505(b)(2) application appears to be an acceptable regulatory approach with docetaxel injection as a potentially acceptable listed drug (LD). Furthermore, the FDA agreed that the completed nonclinical studies are sufficient to support the initiation of the clinical trial of ATI-1123 in patients with platinum-sensitive small cell lung cancer who have progressed after initiation of first-line therapy.

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