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A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

Study acronym: TROPION-Lung12
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jun 30, 2027 to Jul 10, 2026 Completion moved earlier from Jun 30, 2027 to Mar 31, 2027 · Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 3 of 7 entries · 1 more Show 4 more changesShow less
    • Completion moved earlier from Jun 30, 2027 to Mar 31, 2027
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv13
  3. Trial sites reduced: 99 → 90 locations Enrollment target: 24 to 25v12 Show 1 more changeShow less
    • Enrollment target: 24 to 25
  4. Enrollment target: estimated 660 to confirmed 24 Primary completion date: May 19, 2033 to Jun 30, 2027 · Trial status: Recruiting to Active, Not Recruiting · Study sites: 228 to 99 · 1 morev11 Show 4 more changesShow less
    • Primary completion date: May 19, 2033 to Jun 30, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 228 to 99
    • Completion date: Jan 19, 2035 to Jun 30, 2027
  5. Study sites: 225 to 228v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Nov 13, 2031 to May 19, 2033 Study sites: 221 to 225v9 Show 1 more changeShow less
    • Study sites: 221 to 225
  2. Primary completion date: May 19, 2033 to Nov 13, 2031 Study sites: 218 to 221v8 Show 1 more changeShow less
    • Study sites: 218 to 221
  3. Site details revised at 71 of 218 sitesv7
  4. Site details revised at 32 of 218 sitesv6
  5. Study sites: 209 to 218v5
  6. Primary completion date: Oct 21, 2031 to May 19, 2033 Study sites: 199 to 209v4 Show 1 more changeShow less
    • Study sites: 199 to 209
  7. Study sites: 187 to 199v3
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 139 to 187 · Primary completion date: Nov 3, 2031 to Oct 21, 2031 · Completion date: Feb 1, 2035 to Jan 19, 2035 · 1 morev2 Show 4 more changesShow less
    • Study sites: 139 to 187
    • Primary completion date: Nov 3, 2031 to Oct 21, 2031
    • Completion date: Feb 1, 2035 to Jan 19, 2035
    • Start date changed from estimate of Oct 28, 2024 to Oct 15, 2024
  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 a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
Trial Details
NCT Number NCT06564844
Lead Sponsor AstraZeneca
Collaborators: Daiichi Sankyo
Conditions Non-small Cell Lung Cancer
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov