Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study sites revised (260)
  2. Trial sites expanded: 253 → 260 locationsv17
  3. Trial sites expanded: 244 → 253 locationsv16
  4. Study sites: 228 to 244v15
  5. Primary completion date: Dec 31, 2027 to Dec 31, 2028v14 Show 5 more changesShow less
    • Enrollment target: 1080 to 1600
    • Study sites: 219 to 228
    • Study completion date: Dec 31, 2028 to Dec 31, 2029
    • Study description expanded, about 12 words
    • Eligibility criteria expanded, about 5 words
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 167 to 219
    • Study description expanded, about 40 words
    v13
  2. Study sites: 108 to 167v12
  3. Study sites: 60 to 108v11
  4. Study sites: 44 to 60
    • Eligibility criteria expanded, about 9 words
    v10
  5. Eligibility criteria shortened, about 4 wordsv9
  6. Enrollment target: 400 to 1080v8 Show 7 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 37 to 44
    • Primary completion date: Sep 30, 2027 to Dec 31, 2027
    • Study completion date: Dec 20, 2027 to Dec 31, 2028
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 2 to 1
    • Study title shortened, about 1 word
  7. Study sites revised (37)v7
  8. Study sites: 33 to 37v6
  9. Study sites: 30 to 33
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 2 entries
    v5
  10. Study sites: 4 to 30v4
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Sep 30, 2023 to Oct 26, 2023
    • Eligibility criteria shortened, about 9 words
    v3
  12. Study title shortened, about 3 wordsv2
  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 is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
Trial Details
NCT Number NCT05899608
Lead Sponsor Summit Therapeutics
Conditions
(from sponsor)		 Non-Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 1,600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov