A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Study acronym: TROPION-Lung15
StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2026 → Jan 11, 2027
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Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 7 more changesShow less
    • Primary completion pushed from Sep 30, 2026 to Jan 11, 2027
    • Trial sites reduced: 303 → 211 locations
    • Enrollment target: estimated 744 to confirmed 768
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 3 of 12 entries
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 3 words
  2. Study sites: 302 to 303v19
  3. Study sites: 300 to 302v18
  4. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 284 to 300
    v17
  5. Primary completion date: Jun 11, 2026 to Sep 30, 2026
    • Study completion date: May 29, 2028 to Sep 27, 2028
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 300 to 284
    v15
  2. Enrollment target: 630 to 744
    • Study sites: 287 to 300
    • Eligibility criteria expanded, about 9 words
    v14
  3. Study completion date: Nov 29, 2027 to May 29, 2028v13
  4. Re-verified, no change to tracked fieldsv12
  5. Study sites: 281 to 287v11
  6. Site details revised at 151 of 281 sitesv10
  7. Study sites: 268 to 281v9
  8. Study sites: 259 to 268v8
  9. Study sites: 224 to 259v7
  10. Study sites: 189 to 224v6
  11. Study sites: 184 to 189
    • Primary completion date: Jun 30, 2026 to Jun 11, 2026
    • Study completion date: Dec 31, 2027 to Nov 29, 2027
    v5
  12. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 184
    • Primary completion date: Sep 8, 2026 to Jun 30, 2026
    • Study completion date: Feb 8, 2028 to Dec 31, 2027
    • Start date changed from estimate of Aug 12, 2024 to Oct 4, 2024
  13. 2 versions Re-verified since Jun 10, 2024, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • 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 study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
Trial Details
NCT Number NCT06417814
Lead Sponsor AstraZeneca
Collaborators: Daiichi Sankyo
Conditions
(from sponsor)		 Metastatic Non-small Cell Lung Cancer
Related terms Carcinoma, Carcinoma, Non-Small-Cell Lung
Enrollment 768 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov