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Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary completion date changed from estimate of Sep 30, 2026 to Jul 15, 2026v13 Show 1 more changeShow less
    • Primary completion date changed from estimate of Sep 30, 2026 to Jul 15, 2026
  2. Primary and study completion pushed from Mar 30, 2026 to Sep 30, 2026v12
  3. 2 versions Re-verified since Oct 13, 2025, no change to tracked fieldsv10-v11
  4. Primary completion date: May 25, 2025 to Mar 30, 2026 Completion date: Feb 28, 2026 to Mar 30, 2026v9 Show 1 more changeShow less
    • Completion date: Feb 28, 2026 to Mar 30, 2026
  5. Primary completion date: Jun 25, 2024 to May 25, 2025 Completion date: Mar 31, 2025 to Feb 28, 2026v8 Show 1 more changeShow less
    • Completion date: Mar 31, 2025 to Feb 28, 2026
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 180 to confirmed 61 · Primary completion date changed from estimate of Aug 25, 2026 to Jun 25, 2024 · Completion date: Sep 3, 2026 to Mar 31, 2025 · 1 morev7 Show 4 more changesShow less
    • Enrollment target: estimated 180 to confirmed 61
    • Primary completion date changed from estimate of Aug 25, 2026 to Jun 25, 2024
    • Completion date: Sep 3, 2026 to Mar 31, 2025
    • Site details revised at 54 of 54 sites
  2. Study sites: 53 to 54v6
  3. Study sites: 46 to 53v5
  4. Study sites: 13 to 46 Study title expanded, about 1 wordv4 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 8 to 13v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 8 · Start date changed from estimate of Jul 11, 2023 to Sep 13, 2023v2 Show 2 more changesShow less
    • Study sites: 1 to 8
    • Start date changed from estimate of Jul 11, 2023 to Sep 13, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor Tuvusertib in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell Lung Cancer (nsqNSCLC) that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies..
Trial Details
NCT Number NCT05882734
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Non-Small Cell Lung Cancer
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov