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Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

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Trial Profile

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2025

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At a glance

  • Drugs Gotistobart (Primary) ; Docetaxel
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PRESERVE-003
  • Sponsors OncoC4

    • Most Recent Events

    • 20 Nov 2024 Status changed from suspended to recruiting.
    • 04 Nov 2024 Status changed from active, no longer recruiting to suspended, according to a BioNTech media release.
    • 04 Nov 2024 According to a BioNTech media release, In October 2024, the FDA placed a partial clinical hold on this trial due to varying results between patient populations. Enrollment of new patients has been paused while patients already enrolled in the trial will continue to receive treatment. Trials evaluating BNT316/ONC-392 in other indications remain unaffected.

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