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

Research & Trial Information

SCHEMA EA5162

Protocol #: EA5162

Cancer Type: Non Small Cell Lung Cancer

Eligibility Criteria:

  1. Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).
  2. Participants must have advanced disease – either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease.
  3. An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any CLIA-certified tissue assay.
  4. Patients must have measurable disease.
  5. Patients must have previously received at least one line of therapy for their advanced lung cancer. There are no restrictions on the maximum number of prior therapies allowed.
  6. Participants may not have received any prior treatment with therapies targeting PDL1, PD1 or CTLA4.
  7. Age ≥ 18 years.
  8. ECOG performance status ≤1.
  9. Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically significant interstitial lung disease or radiation pneumonitis.
  10. Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation field includes the lungs, radiation must be completed at least two weeks before starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting to treatment. At least six months (180 days) must have elapsed from radiation given with curative intent.
  11. Participants may not have clinically symptomatic brain metastases or leptomeningeal disease. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on a stable dose for two weeks (14 days) prior to study treatment and are clinically asymptomatic.
  12. Patients must have an ECHO or a nuclear study (MUGA or First Pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible.
  13. No history of QT prolongation associated with other medications that required discontinuation of that medication. Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. Symptomatic heart failure – New York Heart Association (NYHA) grade II-IV.
  14. Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed.
  15. Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment.
  16. Participants may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirement.

 

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Flint, MI 48503

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