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A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 295 → 300 locations Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 3 of 10 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 10 entries
  2. Minor Trial sites expanded: 287 → 295 locationsv17
  3. Minor Enrollment increased: 878 → 1160 participants Study sites: 286 to 287 · Secondary endpoints: details revised at 10 of 10 entries · Eligibility criteria expanded, about 4 words · 2 morev16 Show 5 more changesShow less
    • Study sites: 286 to 287
    • Secondary endpoints: details revised at 10 of 10 entries
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 4 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Notable Primary completion pushed from May 10, 2029 to Nov 18, 2030 Trial sites expanded: 283 → 286 locations · Completion pushed from Mar 25, 2030 to Nov 18, 2030v15 Show 2 more changesShow less
    • Trial sites expanded: 283 → 286 locations
    • Completion pushed from Mar 25, 2030 to Nov 18, 2030
  5. Minor Study sites: 282 to 283v14
Show 12 earlier versionsHide 12 earlier versions
  1. Minor Site details revised at 7 of 282 sitesv13
  2. Minor Study sites: 281 to 282v12
  3. Minor Study sites: 279 to 281v11
  4. Minor Study sites: 276 to 279v10
  5. Minor Study sites: 275 to 276v9
  6. Minor Site details revised at 21 of 275 sitesv8
  7. Minor Study sites: 271 to 275v7
  8. Minor Study sites: 261 to 271v6
  9. Minor Study sites: 241 to 261 Secondary endpoints: details revised at 1 of 10 entries · Eligibility criteria expanded, about 5 wordsv5 Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 10 entries
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  10. Minor Study sites: 227 to 241 Completion date: Mar 20, 2030 to Mar 25, 2030v4 Show 1 more changeShow less
    • Completion date: Mar 20, 2030 to Mar 25, 2030
  11. Minor Study sites: 211 to 227 Primary completion date: May 14, 2029 to May 10, 2029 · Completion date: Mar 25, 2030 to Mar 20, 2030v3 Show 2 more changesShow less
    • Primary completion date: May 14, 2029 to May 10, 2029
    • Completion date: Mar 25, 2030 to Mar 20, 2030
  12. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 148 to 211 · Start date changed from estimate of Nov 29, 2024 to Nov 27, 2024 · Secondary endpoints: 11 to 10v2 Show 3 more changesShow less
    • Study sites: 148 to 211
    • Start date changed from estimate of Nov 29, 2024 to Nov 27, 2024
    • Secondary endpoints: 11 to 10

    See this version in full on ClinicalTrials.gov ↗

  1. Minor 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.
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1.
Trial Details
NCT Number NCT06627647
Lead Sponsor AstraZeneca
Conditions Non-squamous Non-small Cell Lung Cancer
Enrollment 1,160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov