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Completed PHASE3 INTERVENTIONAL 1-arm NCT01853826

An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Sponsor: Boehringer Ingelheim

Conditions Carcinoma, Non-Small-Cell Lung
Interventions Afatinib
Updated 58 times since 2017 Last updated: Apr 10, 2025 Started: Jul 17, 2013 Primary completion: Mar 6, 2024 Completion: Mar 6, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Carcinoma, Non-Small-Cell Lung and is currently completed. Boehringer Ingelheim leads this study, which shows 58 recorded versions since 2013 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshot~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~May 2019 · 3 months · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Mar 2020 · 3 months · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · 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 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 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 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · 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 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · 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 – ~Jan 2024 · 5 months · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Apr 2024 · 2 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

58 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. May 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — May 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

▶ Show 53 earlier versions

  1. Feb 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Jan 2024 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Aug 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Jun 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE3

  6. May 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE3

  7. Apr 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE3

  8. Mar 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

  9. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  10. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  11. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE3

  12. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE3

  13. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE3

  14. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  15. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  16. May 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

  17. Apr 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE3

  18. Mar 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE3

  19. Feb 2022 — Mar 2022 [monthly]

    Active Not Recruiting PHASE3

  20. Jan 2022 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

  21. Dec 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE3

  22. Nov 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE3

  23. Oct 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE3

  24. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

  25. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  26. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  27. Apr 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  28. Mar 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE3

  29. Feb 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE3

  30. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  31. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  32. Nov 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE3

  33. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

  34. Sep 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  35. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE3

  36. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

  37. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

  38. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

  39. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE3

  40. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE3

  41. Dec 2019 — Mar 2020 [monthly]

    Active Not Recruiting PHASE3

  42. Oct 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  43. Aug 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  44. Jun 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

  45. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE3

  46. Feb 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  47. Dec 2018 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

  48. Sep 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

  49. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

  50. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  51. Oct 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE3

  52. Aug 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE3

  53. Jan 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Jul 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Boehringer Ingelheim
Data source: Boehringer Ingelheim

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

Study Locations

A Coruña, Spain , AT Albans, Australia , Alessandria, Italy , Alicante, Spain , Ancona, Italy , Athens, Greece , Avellino, Italy , Aviano (PN), Italy , Badalona, Spain , Barakaldo (Bilbao), Spain and 81 more locations