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A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

Study acronym: MARIPOSA-2
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 64 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Notable Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Completion pushed from Nov 30, 2027 to Jul 3, 2028 · Eligibility criteria expanded, about 13 words · Study sites revised (249) Show 3 more changesShow less
    • Completion pushed from Nov 30, 2027 to Jul 3, 2028
    • Eligibility criteria expanded, about 13 words
    • Study sites revised (249)
  3. Minor Completion moved earlier from Mar 1, 2028 to Nov 30, 2027 Completion pushed from Nov 30, 2027 to Mar 1, 2028v62 Show 1 more changeShow less
    • Completion pushed from Nov 30, 2027 to Mar 1, 2028
  4. Minor Completion date: Nov 30, 2027 to Mar 1, 2028v61
  5. Minor Study sites revised (249)v60 See this version in full on ClinicalTrials.gov ↗
  6. Minor Re-verified, no change to tracked fieldsv59
  7. Minor Completion pushed from Sep 30, 2026 to Nov 30, 2027 Study sites: 247 to 249v58 Show 1 more changeShow less
    • Study sites: 247 to 249
  8. Minor Study sites revised (247)v57 See this version in full on ClinicalTrials.gov ↗
  9. Minor Site details revised at 1 of 247 sitesv56
  10. Minor 7 versions Re-verified since Jun 20, 2025, no change to tracked fieldsv49-v55
  11. Minor Study sites revised (247)v48 See this version in full on ClinicalTrials.gov ↗
  12. Minor Site details revised at 1 of 247 sitesv47
  13. Minor Re-verified, no change to tracked fieldsv46
  14. Notable Results first posted: Apr 16, 2025v45
  15. Minor Secondary endpoints: details revised at 16 of 16 entries Site details revised at 1 of 247 sitesv44 Show 1 more changeShow less
    • Site details revised at 1 of 247 sites
  16. Minor Study sites revised (247)v43 See this version in full on ClinicalTrials.gov ↗
  17. Notable Primary endpoints: 1 to 3 Secondary endpoints expanded, about 195 words · Study sites revised (247)v42 Show 2 more changesShow less
    • Secondary endpoints expanded, about 195 words
    • Study sites revised (247)

    See this version in full on ClinicalTrials.gov ↗

  18. Minor Completion date: Jun 30, 2026 to Sep 30, 2026 Secondary endpoints shortened, about 120 words · Study sites revised (247)v41 Show 2 more changesShow less
    • Secondary endpoints shortened, about 120 words
    • Study sites revised (247)

    See this version in full on ClinicalTrials.gov ↗

  19. Minor Study sites revised (247)v40 See this version in full on ClinicalTrials.gov ↗
  20. Minor Completion date: Dec 8, 2025 to Jun 30, 2026 Study sites revised (247)v39 Show 1 more changeShow less
  21. Minor Study sites revised (247)v38 See this version in full on ClinicalTrials.gov ↗
  22. Minor Study sites revised (247)v37 See this version in full on ClinicalTrials.gov ↗
  23. Minor Study sites revised (247)v36 See this version in full on ClinicalTrials.gov ↗
  24. Minor Study sites revised (247)v35 See this version in full on ClinicalTrials.gov ↗
  25. Minor Eligibility criteria revised Study sites revised (247)v34 Show 1 more changeShow less
  26. Minor Study sites revised (247)v33 See this version in full on ClinicalTrials.gov ↗
  27. Minor Study sites revised (247)v32 See this version in full on ClinicalTrials.gov ↗
  28. Minor Study sites: 248 to 247v31
  29. Minor Study sites revised (248)v30 See this version in full on ClinicalTrials.gov ↗
  30. Minor Completion date: Dec 7, 2025 to Dec 8, 2025 Study sites revised (248)v29 Show 1 more changeShow less
  31. Minor Study sites revised (248)v28 See this version in full on ClinicalTrials.gov ↗
  32. Minor Re-verified, no change to tracked fieldsv27
  33. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 690 to confirmed 776 · Study sites: 246 to 248 · Primary completion date changed from estimate of May 31, 2023 to Jul 10, 2023v26 Show 3 more changesShow less
    • Enrollment target: estimated 690 to confirmed 776
    • Study sites: 246 to 248
    • Primary completion date changed from estimate of May 31, 2023 to Jul 10, 2023
  34. Minor Study sites: 244 to 246 Completion date: Dec 29, 2026 to Dec 7, 2025v25 Show 1 more changeShow less
    • Completion date: Dec 29, 2026 to Dec 7, 2025
  35. Minor Study sites revised (244)v24 See this version in full on ClinicalTrials.gov ↗
  36. Minor Enrollment target: 600 to 690 Site details revised at 6 of 244 sitesv23 Show 1 more changeShow less
    • Site details revised at 6 of 244 sites
  37. Minor Study sites: 310 to 244v22
  38. Minor Study sites: 309 to 310v21
  39. Minor Study sites revised (309) Study arms: 3 to 5v20 Show 1 more changeShow less
  40. Minor Completion date: Nov 17, 2025 to Dec 29, 2026 Study sites revised (309)v19 Show 1 more changeShow less
  41. Minor Study sites: 305 to 309v18
  42. Minor Re-verified, no change to tracked fieldsv17
  43. Minor Study sites: 304 to 305v16
  44. Minor Study sites: 303 to 304v15
  • 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 this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.
Trial Details
NCT Number NCT04988295
Lead Sponsor Janssen Research & Development, LLC
Conditions Carcinoma, Non-Small-Cell Lung
Enrollment 776 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov