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Terminated PHASE1/PHASE2 INTERVENTIONAL 4-arm NCT02349633

Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)

PHASE 1/2 OPEN-LABEL STUDY OF PF-06747775 (EPIDERMAL GROWTH FACTOR RECEPTOR T790M INHIBITOR) IN PATIENTS WITH ADVANCED EPIDERMAL GROWTH FACTOR RECEPTOR MUTANT (DEL 19 OR L858R ± T790M) NON-SMALL CELL LUNG CANCER

Sponsor: Pfizer

Conditions Non-Small Cell Lung Cancer
Interventions Avelumab PF-06747775 Palbociclib
Updated 26 times since 2017 Last updated: May 13, 2021 Started: May 14, 2015 Primary completion: May 28, 2020 Completion: May 28, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was ended for strategic reasons and changes in the external environment.~The safety profile and risk benefit ratio for PF-0674775 remained unchanged.

This PHASE1/PHASE2 trial investigates Non-Small Cell Lung Cancer and is currently terminated or withdrawn. Pfizer leads this study, which shows 26 recorded versions since 2015 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

There remains an unmet medical need to develop EGFR TKI agents that effectively target both the single activating mutations of del 19 and L858R, and the secondary resistance mutation T790M, while sparing WT EGFR. Drugs active against the resistance mutation will enable molecularly targeted therapy with a more favorable toxicity profile than the current standard of cytotoxic chemotherapy platinum based doublets. Furthermore, by having a wide margin of selectivity favoring the EGFR mutants versus WT EGFR, PF 06747775 is likely to be positioned to improve patient outcomes from an efficacy and safety perspective.

There remains an unmet medical need to develop EGFR TKI agents that effectively target both the single activating mutations of del 19 and L858R, and the secondary resistance mutation T790M, while sparing WT EGFR. Drugs active against the resistance mutation will enable molecularly targeted therapy with a more favorable toxicity profile than the current standard of cytotoxic chemotherapy platinum based doublets. Furthermore, by having a wide margin of selectivity favoring the EGFR mutants versus WT EGFR, PF 06747775 is likely to be positioned to improve patient outcomes from an efficacy and safety perspective.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Oct 2017 · 8 months · monthly snapshot~Oct 2017 – ~Nov 2017 · 31 days · monthly snapshot~Nov 2017 – ~Feb 2018 · 3 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Oct 2018 · 2 months · monthly snapshot~Oct 2018 – ~Jan 2019 · 3 months · monthly snapshot~Jan 2019 – ~Aug 2019 · 7 months · monthly snapshot~Aug 2019 – ~Feb 2020 · 6 months · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~Jul 2020 · 3 months · monthly snapshot~Jul 2020 – ~Sep 2020 · 2 months · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Jul 2024 · 28 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 7 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

26 versions recorded

  1. Jan 2026 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Sep 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Mar 2022 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

▶ Show 21 earlier versions

  1. Jan 2022 — Mar 2022 [monthly]

    Terminated PHASE1_PHASE2

  2. Dec 2021 — Jan 2022 [monthly]

    Terminated PHASE1_PHASE2

  3. Sep 2021 — Dec 2021 [monthly]

    Terminated PHASE1_PHASE2

    Phase: PHASE2 → PHASE1_PHASE2

  4. Jan 2021 — Sep 2021 [monthly]

    Terminated PHASE2

  5. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE2

  6. Oct 2020 — Nov 2020 [monthly]

    Terminated PHASE2

  7. Sep 2020 — Oct 2020 [monthly]

    Terminated PHASE2

    Status: Completed → Terminated

  8. Jul 2020 — Sep 2020 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  9. Apr 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE2

  10. Feb 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE2

  11. Aug 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE2

  12. Jan 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE2

  13. Oct 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE2

  14. Aug 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  15. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  16. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  17. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  18. Nov 2017 — Feb 2018 [monthly]

    Recruiting PHASE2

  19. Oct 2017 — Nov 2017 [monthly]

    Recruiting PHASE2

    Phase: PHASE1_PHASE2 → PHASE2

  20. Feb 2017 — Oct 2017 [monthly]

    Recruiting PHASE1_PHASE2

  21. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

May 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pfizer
Data source: Pfizer

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

Study Locations