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Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT04194944

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (LIBRETTO-431)

LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Sponsor: Eli Lilly and Company

Updated 46 times since 2020 Last updated: Oct 17, 2025 Started: Feb 17, 2020 Primary completion: May 1, 2023 Completion: Jun 30, 2030
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04194944, this PHASE3 trial focuses on Non-Small Cell Lung Cancer and remains ongoing. Sponsored by Eli Lilly and Company, it has been updated 46 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~May 2023 · 2 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshot~Nov 2023 – ~Apr 2024 · 5 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Mar 2026 · 3 months · monthly snapshot~Mar 2026 – present · 3 months · monthly snapshot

Change History

46 versions recorded
  1. Mar 2026 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Dec 2025 — Mar 2026 [monthly]

    Active Not Recruiting PHASE3

  3. Nov 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Sep 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE3

  5. May 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

Show 41 earlier versions
  1. Mar 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE3

  2. Feb 2025 — Mar 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  6. Nov 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE3

  7. Sep 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE3

  8. Aug 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE3

  9. Jul 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE3

  10. Jun 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE3

  11. May 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE3

  12. Mar 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE3

  13. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  14. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  15. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  16. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  17. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  18. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  19. May 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  20. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  21. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  22. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  23. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  24. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  25. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  26. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  27. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  28. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  29. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

  30. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  31. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  32. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  33. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE3

  34. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE3

  35. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  36. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  37. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  38. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  39. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  40. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  41. Jan 2020 — Apr 2020 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eli Lilly and Company
  • Loxo Oncology, Inc.
Data source: Eli Lilly and Company

For direct contact, visit the study record on ClinicalTrials.gov .