deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT02197234

Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC

A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Simvastatin (a Sensitive CYP3A4 Substrate) in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

Sponsor: AstraZeneca

Conditions Non Small Cell Lung Cancer
Interventions AZD9291 tablet dosing Pharmacokinetic sampling - AZ5140 and AZ7550 Pharmacokinetic sampling - AZD9291 Pharmacokinetic sampling - simvastatin Simvastatin
Updated 36 times since 2017 Last updated: Nov 13, 2025 Started: Dec 22, 2014 Primary completion: Apr 30, 2015 Completion: Jun 3, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Non Small Cell Lung Cancer, this trial is completed. The trial is conducted by AstraZeneca and has accumulated 36 data snapshots since 2014. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Mar 2019 · 4 months · monthly snapshot~Mar 2019 – ~Jun 2019 · 3 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Dec 2019 · 4 months · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~Jul 2020 · 3 months · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~Jul 2022 · 4 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~Aug 2023 · 4 months · monthly snapshot~Aug 2023 – ~Nov 2023 · 3 months · monthly snapshot~Nov 2023 – ~Mar 2024 · 4 months · monthly snapshot~Mar 2024 – ~May 2024 · 2 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Jan 2025 · 3 months · monthly snapshot~Jan 2025 – ~Sep 2025 · 8 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 7 months · monthly snapshot

Change History

36 versions recorded

  1. Dec 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE1

  3. Jan 2025 — Sep 2025 [monthly]

    Completed PHASE1

  4. Oct 2024 — Jan 2025 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  5. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE1

▶ Show 31 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  2. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Mar 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Nov 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Aug 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE1

  6. Apr 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE1

  7. Feb 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE1

  8. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE1

  9. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

  10. Mar 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

  11. Dec 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE1

  12. Nov 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE1

  13. Sep 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE1

  14. May 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1

  15. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE1

  16. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  17. Oct 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE1

  18. Jul 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE1

  19. Apr 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE1

  20. Jan 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1

  21. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE1

  22. Aug 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE1

  23. Jun 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE1

  24. Mar 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1

  25. Nov 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE1

  26. Sep 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE1

  27. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE1

  28. Aug 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

  29. Jul 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE1

  30. Feb 2017 — Jul 2017 [monthly]

    Active Not Recruiting PHASE1

  31. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Dec 2014

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AstraZeneca
Data source: AstraZeneca

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

Study Locations

Angers, France , Atlanta, United States , Badalona, Spain , Barcelona, Spain , Dijon, France , Leuven, Belgium , Madrid, Spain , Marseille, France , Rennes, France , Saint-Herblain, France and 3 more locations