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Premedication to Reduce Amivantamab Associated Infusion Related Reactions

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 51 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Completion pushed from Mar 31, 2027 to Sep 30, 2027 · Eligibility criteria expanded, about 12 words · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Completion pushed from Mar 31, 2027 to Sep 30, 2027
    • Eligibility criteria expanded, about 12 words
    • Publications: details revised at 1 of 1 entry
  3. 3 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv47-v49
  4. Completion pushed from Jul 30, 2026 to Mar 31, 2027v46
  5. 6 versions Re-verified since Nov 6, 2025, no change to tracked fieldsv40-v45
Show 38 earlier versionsHide 38 earlier versions
  1. Results first posted: Oct 20, 2025 Primary endpoint revised · Enrollment target: 73 to 68 · Secondary endpoints: 11 to 8 · 1 morev39 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 73 to 68
    • Secondary endpoints: 11 to 8
    • Study sites revised (36)

    See this version in full on ClinicalTrials.gov ↗

  2. Completion date: Oct 29, 2025 to Jul 30, 2026v38
  3. Re-verified, no change to tracked fieldsv37
  4. Site details revised at 1 of 36 sitesv36
  5. 7 versions Re-verified since Jan 10, 2025, no change to tracked fieldsv29-v35
  6. Primary completion date changed from estimate of Dec 15, 2024 to Mar 29, 2024v28
  7. Re-verified, no change to tracked fieldsv27
  8. Enrollment target: 74 to 73v26
  9. 2 versions Re-verified since Sep 9, 2024, no change to tracked fieldsv24-v25
  10. Completion date: Aug 31, 2026 to Oct 29, 2025v23
  11. Study sites revised (36)v22 See this version in full on ClinicalTrials.gov ↗
  12. 2 versions Re-verified since May 21, 2024, no change to tracked fieldsv20-v21
  13. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 67 to confirmed 74 · Site details revised at 36 of 36 sitesv19 Show 2 more changesShow less
    • Enrollment target: estimated 67 to confirmed 74
    • Site details revised at 36 of 36 sites
  14. Re-verified, no change to tracked fieldsv18
  15. Completion date: Dec 25, 2025 to Aug 31, 2026 Study sites revised (36)v17 Show 1 more changeShow less
    • Study sites revised (36)

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites revised (36)v16 See this version in full on ClinicalTrials.gov ↗
  17. Enrollment target: 126 to 67 Study sites: 32 to 36v15 Show 1 more changeShow less
    • Study sites: 32 to 36
  18. Study sites: 29 to 32v14
  19. Study sites: 27 to 29 Completion date: Dec 16, 2025 to Dec 25, 2025v13 Show 1 more changeShow less
    • Completion date: Dec 16, 2025 to Dec 25, 2025
  20. Study sites: 20 to 27v12
  21. Enrollment target: 120 to 126 Study sites: 19 to 20v11 Show 1 more changeShow less
    • Study sites: 19 to 20
  22. Study sites: 17 to 19v10
  23. Study sites: 15 to 17v9
  24. Study sites: 7 to 15 Primary completion date: Jun 30, 2024 to Dec 15, 2024v8 Show 1 more changeShow less
    • Primary completion date: Jun 30, 2024 to Dec 15, 2024
  25. Trial status: Not Yet Recruiting to Recruiting Study sites: 28 to 7 · Completion date: Jun 30, 2024 to Dec 16, 2025 · Start date changed from estimate of Apr 25, 2023 to May 18, 2023 · 4 morev7 Show 7 more changesShow less
    • Study sites: 28 to 7
    • Completion date: Jun 30, 2024 to Dec 16, 2025
    • Start date changed from estimate of Apr 25, 2023 to May 18, 2023
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints revised (11)
    • Study description shortened, about 197 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  26. Start date: Mar 31, 2023 to Apr 25, 2023v6
  27. Study sites: 22 to 28v5
  28. Study sites: 18 to 22 Start date: Apr 9, 2023 to Mar 31, 2023v4 Show 1 more changeShow less
    • Start date: Apr 9, 2023 to Mar 31, 2023
  29. Study sites: 16 to 18v3
  30. Study sites: 13 to 16 Primary completion date: Jun 3, 2024 to Jun 30, 2024v2 Show 1 more changeShow less
    • Primary completion date: Jun 3, 2024 to Jun 30, 2024
  • 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 the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of first-dose infusion related reactions.
Trial Details
NCT Number NCT05663866
Lead Sponsor Janssen Research & Development, LLC
Conditions Carcinoma, Non-Small-Cell Lung
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov