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KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Trial Profile

KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Oct 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Sacituzumab Tirumotecan (Primary) ; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel; Pemetrexed
  • Indications Non-small cell lung cancer
  • Focus Therapeutic Use
  • Acronyms KEYMAKER-U01 Substudy 01E
  • Sponsors Merck Sharp & Dohme

Most Recent Events

  • 29 Aug 2025 Planned End Date changed from 7 Feb 2032 to 6 Feb 2032.
  • 29 Aug 2025 Planned primary completion date changed from 5 Nov 2031 to 6 Feb 2032.
  • 17 Mar 2025 Status changed from not yet recruiting to recruiting.

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