Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: T790M+ Testing; Baseline Visit Blood & Urine Testing; Baseline ECG; Visual Slit-Lamp Testing; AZD9291 Dosing
Intervention description: If a previous lab report is unavailable, the patient will need to have T790M+ testing.; Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria; ECG to ensure absence of any cardiac abnormality; Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms; Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)
Intervention MeSH terms: Osimertinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3017.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: NSCLC; EGFRm; T790M

Summary:

      The aim of this study is to assess the efficacy and safety of single agent AZD9291 in a real
      world setting in adult patients with advanced or metastatic, epidermal growth factor receptor
      (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), who have received prior
      EGFR-tyrosine kinase inhibitor (TKI) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of signed and dated written informed consent by the patient or legally
             acceptable representative prior to any study-specific procedures

          2. Adults (according to each country regulations for age of majority)

          3. Locally advanced (stage IIIB) or metastatic (stage IV) EGFRm NSCLC, not amenable to
             curative surgery or radiotherapy, with confirmation of the presence of the T790M
             mutation

          4. Prior therapy with an EGFR-TKI. Patients may have also received additional lines of
             treatment

          5. World Health Organization (WHO) performance status 0-2

          6. Adequate bone marrow reserve and organ function as demonstrated by complete blood
             count, biochemistry in blood and urine at baseline (please refer to IB for guidance)

          7. ECG recording at baseline showing absence of any cardiac abnormality as per exclusion
             criterion #6

          8. Female patients of childbearing potential must be using adequate contraceptive
             measures, must not be breast feeding, and must have a negative pregnancy test prior to
             start of dosing. Otherwise, they must have evidence of nonchildbearing potential

          9. Male patients must be willing to use barrier contraception, i.e., condoms

        Exclusion Criteria:

          1. Previous (within 6 months) or current treatment with AZD9291

          2. Patients currently receiving (or unable to stop use at least 1 week prior to receiving
             the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of
             cytochrome P450 (CYP) 3A4

          3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled
             hypertension, active bleeding diatheses, active infection including hepatitis B,
             hepatitis C, and human immunodeficiency virus, or significantly impaired bone marrow
             reserve or organ function, including hepatic and renal impairment, which in the
             investigator's opinion would significantly alter the risk/benefit balance.

          4. Patient with symptomatic central nervous system (CNS) metastases who is neurologically
             unstable or has required increasing doses of steroids to manage CNS symptoms within
             the 2 weeks prior to start AZD9291 administration;

          5. Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid
             treatment, or any evidence of clinically active ILD

          6. Any of the following cardiac criteria:

               1. Mean resting corrected QT interval (QTcF) > 470 ms using Fredericia's formula :

               2. Any clinically important abnormalities in rhythm, conduction or morphology of
                  resting ECG (e.g., complete left bundle branch block, third degree heart block,
                  second degree heart block)

               3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic
                  events

          7. Any unresolved toxicity from prior therapy CTCAE > grade 3 at the time of starting
             treatment

          8. History of hypersensitivity to excipients of AZD9291 or to drugs with a similar
             chemical structure or class to AZD9291