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A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Feb 5, 2029 → Jul 1, 2030
See other at-risk trials from AstraZeneca

Record History

  1. Trial sites expanded: 325 → 328 locations Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 3 of 10 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 3 of 10 entries
  2. Trial sites expanded: 312 → 325 locationsv15
  3. Primary completion pushed from Feb 5, 2029 to Jul 1, 2030 Enrollment increased: 880 → 1160 participants · Trial sites expanded: 303 → 312 locations · Completion pushed from Oct 8, 2029 to Jul 1, 2030 · 4 morev14 Show 7 more changesShow less
    • Enrollment increased: 880 → 1160 participants
    • Trial sites expanded: 303 → 312 locations
    • Completion pushed from Oct 8, 2029 to Jul 1, 2030
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 10 of 10 entries
    • Study description expanded, about 3 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 301 to 303v13
  5. Study sites: 300 to 301v12
Show 10 earlier versionsHide 10 earlier versions
  1. Site details revised at 6 of 300 sitesv11
  2. Study sites: 298 to 300v10
  3. Study sites: 297 to 298v9
  4. Study sites: 295 to 297v8
  5. Study sites: 290 to 295v7
  6. Study sites: 288 to 290v6
  7. Study sites: 283 to 288v5
  8. Study sites: 263 to 283 Eligibility criteria shortened, about 45 words · Secondary endpoints: details revised at 1 of 10 entriesv4 Show 2 more changesShow less
    • Eligibility criteria shortened, about 45 words
    • Secondary endpoints: details revised at 1 of 10 entries

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 238 to 263v3
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 219 to 238 · Start date changed from estimate of Dec 2, 2024 to Nov 18, 2024v2 Show 2 more changesShow less
    • Study sites: 219 to 238
    • Start date changed from estimate of Dec 2, 2024 to Nov 18, 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.
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
Trial Details
NCT Number NCT06692738
Lead Sponsor AstraZeneca
Conditions Non-small Cell Lung Cancer
Enrollment 1,160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov