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Recruiting PHASE2 INTERVENTIONAL 1-arm NCT03191149

Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR

Sponsor: National Cancer Institute (NCI)

Conditions Advanced Lung Non-Small Cell Carcinoma Recurrent Lung Non-Small Cell Carcinoma Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IV Lung Non-Small Cell Cancer AJCC v7
Interventions Biospecimen Collection Computed Tomography with Contrast Echocardiography Test Magnetic Resonance Imaging Multigated Acquisition Scan Osimertinib
Updated 86 times since 2017 Last updated: Mar 12, 2026 Started: Apr 25, 2018 Primary completion: Jun 30, 2027 Completion: Jun 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Advanced Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, this trial is actively recruiting participants. The trial is conducted by National Cancer Institute (NCI) and has accumulated 86 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

PRIMARY OBJECTIVE: I. To evaluate the best objective response rate of osimertinib (AZD9291) among patients with EGFR exon 20 insertions. SECONDARY OBJECTIVES: I. To determine the safety profile of 160 mg once daily (QD) dose of osimertinib (AZD9291) in patients with EGFR Exon 20 insertion mutations. II. To determine the progression-free survival. III. To determine the overall survival. TERTIARY OBJECTIVES: I. To characterize molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (DNA). II. To evaluate biomarkers of response to treatment through retrospective analyses of pre-treatment tumor tissue. III. To identify resistance mechanisms to osimertinib (AZD9291) through post-progression tumor biopsies and circulating tumor (ct)DNA. OUTLINE: Patients receive osimertinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA), magnetic resonance imaging (MRI) or computed tomography (CT) with contrast, and collection of blood samples throughout the trial. After completion of study treatment, patients are followed up at 30 days and every 3 months for up to 5 years.

PRIMARY OBJECTIVE:

I. To evaluate the best objective response rate of osimertinib (AZD9291) among patients with EGFR exon 20 insertions.

SECONDARY OBJECTIVES:

I. To determine the safety profile of 160 mg once daily (QD) dose of osimertinib (AZD9291) in patients with EGFR Exon 20 insertion mutations.

II. To determine the progression-free survival. III. To determine the overall survival.

TERTIARY OBJECTIVES:

I. To characterize molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (DNA).

II. To evaluate biomarkers of response to treatment through retrospective analyses of pre-treatment tumor tissue.

III. To identify resistance mechanisms to osimertinib (AZD9291) through post-progression tumor biopsies and circulating tumor (ct)DNA.

OUTLINE:

Patients receive osimertinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA), magnetic resonance imaging (MRI) or computed tomography (CT) with contrast, and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up at 30 days and every 3 months for up to 5 years.

Status Flow

~Aug 2017 – ~Dec 2017 · 4 months · monthly snapshot~Dec 2017 – ~May 2018 · 5 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Mar 2020 · 2 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 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Jun 2021 · 3 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · 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 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Jan 2023 · 2 months · 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 – ~Oct 2023 · 2 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Aug 2025 · 31 days · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Feb 2026 – present · 2 months · monthly snapshot~Mar 2026 – present · 34 days · monthly snapshot~Mar 2026 – present · 34 days · monthly snapshot

Change History

86 versions recorded

  1. Mar 2026 — Present [monthly]

    Recruiting PHASE2

  2. Mar 2026 — Present [monthly]

    Recruiting PHASE2

  3. Feb 2026 — Mar 2026 [monthly]

    Recruiting PHASE2

  4. Feb 2026 — Present [monthly]

    Recruiting PHASE2

  5. Jan 2026 — Present [monthly]

    Recruiting PHASE2

▶ Show 81 earlier versions

  1. Dec 2025 — Feb 2026 [monthly]

    Recruiting PHASE2

  2. Nov 2025 — Dec 2025 [monthly]

    Recruiting PHASE2

  3. Oct 2025 — Nov 2025 [monthly]

    Recruiting PHASE2

  4. Sep 2025 — Oct 2025 [monthly]

    Recruiting PHASE2

  5. Aug 2025 — Sep 2025 [monthly]

    Recruiting PHASE2

  6. Jul 2025 — Aug 2025 [monthly]

    Recruiting PHASE2

  7. Jun 2025 — Jul 2025 [monthly]

    Recruiting PHASE2

  8. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE2

  9. Apr 2025 — May 2025 [monthly]

    Recruiting PHASE2

  10. Mar 2025 — Apr 2025 [monthly]

    Recruiting PHASE2

  11. Feb 2025 — Mar 2025 [monthly]

    Recruiting PHASE2

  12. Jan 2025 — Feb 2025 [monthly]

    Recruiting PHASE2

  13. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE2

  14. Nov 2024 — Dec 2024 [monthly]

    Recruiting PHASE2

  15. Oct 2024 — Nov 2024 [monthly]

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  16. Sep 2024 — Oct 2024 [monthly]

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  17. Aug 2024 — Sep 2024 [monthly]

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  18. Jul 2024 — Aug 2024 [monthly]

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  19. Jun 2024 — Jul 2024 [monthly]

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  20. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE2

  21. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE2

  22. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE2

  23. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE2

  24. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE2

  25. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE2

  26. Nov 2023 — Dec 2023 [monthly]

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  27. Oct 2023 — Nov 2023 [monthly]

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  28. Aug 2023 — Oct 2023 [monthly]

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  29. Jul 2023 — Aug 2023 [monthly]

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  30. Jun 2023 — Jul 2023 [monthly]

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  31. May 2023 — Jun 2023 [monthly]

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  32. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE2

  33. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE2

  34. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE2

  35. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE2

    Status: Suspended → Recruiting

  36. Nov 2022 — Jan 2023 [monthly]

    Suspended PHASE2

  37. Sep 2022 — Nov 2022 [monthly]

    Suspended PHASE2

  38. Jul 2022 — Sep 2022 [monthly]

    Suspended PHASE2

  39. Apr 2022 — Jul 2022 [monthly]

    Suspended PHASE2

  40. Mar 2022 — Apr 2022 [monthly]

    Suspended PHASE2

  41. Feb 2022 — Mar 2022 [monthly]

    Suspended PHASE2

  42. Jan 2022 — Feb 2022 [monthly]

    Suspended PHASE2

  43. Dec 2021 — Jan 2022 [monthly]

    Suspended PHASE2

  44. Nov 2021 — Dec 2021 [monthly]

    Suspended PHASE2

  45. Sep 2021 — Nov 2021 [monthly]

    Suspended PHASE2

  46. Jun 2021 — Sep 2021 [monthly]

    Suspended PHASE2

  47. Mar 2021 — Jun 2021 [monthly]

    Suspended PHASE2

  48. Feb 2021 — Mar 2021 [monthly]

    Suspended PHASE2

  49. Jan 2021 — Feb 2021 [monthly]

    Suspended PHASE2

  50. Nov 2020 — Jan 2021 [monthly]

    Suspended PHASE2

  51. Oct 2020 — Nov 2020 [monthly]

    Suspended PHASE2

  52. Sep 2020 — Oct 2020 [monthly]

    Suspended PHASE2

  53. Aug 2020 — Sep 2020 [monthly]

    Suspended PHASE2

  54. Jul 2020 — Aug 2020 [monthly]

    Suspended PHASE2

  55. Jun 2020 — Jul 2020 [monthly]

    Suspended PHASE2

  56. May 2020 — Jun 2020 [monthly]

    Suspended PHASE2

  57. Apr 2020 — May 2020 [monthly]

    Suspended PHASE2

  58. Mar 2020 — Apr 2020 [monthly]

    Suspended PHASE2

  59. Jan 2020 — Mar 2020 [monthly]

    Suspended PHASE2

  60. Dec 2019 — Jan 2020 [monthly]

    Suspended PHASE2

  61. Nov 2019 — Dec 2019 [monthly]

    Suspended PHASE2

  62. Oct 2019 — Nov 2019 [monthly]

    Suspended PHASE2

  63. Sep 2019 — Oct 2019 [monthly]

    Suspended PHASE2

  64. Aug 2019 — Sep 2019 [monthly]

    Suspended PHASE2

    Status: Recruiting → Suspended

  65. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE2

  66. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE2

  67. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE2

  68. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE2

  69. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE2

  70. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE2

  71. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE2

  72. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE2

  73. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE2

  74. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE2

  75. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE2

  76. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  77. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  78. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  79. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  80. Dec 2017 — May 2018 [monthly]

    Not Yet Recruiting PHASE2

  81. Aug 2017 — Dec 2017 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

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

Study Locations

Aberdeen, United States , Allentown, United States , Alma, United States , Alpena, United States , Alton, United States , Anaconda, United States , Anchorage, United States , Ann Arbor, United States , Atlanta, United States , Aurora, United States and 219 more locations