deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT02163733

Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer

An Open-label, Randomised, Phase I, Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

Sponsor: AstraZeneca

Conditions Advanced (Inoperable) Non Small Cell Lung Cancer Advanced Non Small Cell Lung Cancer
Interventions AZD9291 tablets Dietary Fasted Dietary High Fat Pharmacokinetic sampling - AZ5140 and AZ7550 Pharmacokinetic sampling - AZD9291
Updated 30 times since 2017 Last updated: Jan 18, 2024 Started: Nov 14, 2014 Primary completion: Mar 24, 2015 Completion: Jan 24, 2023
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 Advanced (Inoperable) Non Small Cell Lung Cancer and Advanced Non Small Cell Lung Cancer, this trial is completed. The trial is conducted by AstraZeneca and has accumulated 30 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 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Dec 2018 · 5 months · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Jun 2019 · 4 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 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · 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 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Feb 2024 · 11 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

30 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Feb 2024 — Jul 2024 [monthly]

    Completed PHASE1

  5. Mar 2023 — Feb 2024 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

▶ Show 25 earlier versions

  1. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE1

  2. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE1

  3. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

  4. Mar 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

  5. Jan 2022 — Mar 2022 [monthly]

    Active Not Recruiting PHASE1

  6. Dec 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE1

  7. Oct 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE1

  8. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE1

  9. May 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1

  10. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE1

  11. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  12. Jul 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE1

  13. Apr 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE1

  14. Jan 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1

  15. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE1

  16. Aug 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE1

  17. Jun 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE1

  18. Feb 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1

  19. Dec 2018 — Feb 2019 [monthly]

    Active Not Recruiting PHASE1

  20. Jul 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE1

  21. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE1

  22. Aug 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

  23. Jul 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE1

  24. Feb 2017 — Jul 2017 [monthly]

    Active Not Recruiting PHASE1

  25. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Nov 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