Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: AZD9291
Intervention description: Once daily tablet 80 mg
Intervention MeSH terms: Osimertinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Phase II, Open Label, Single-arm study, Safety and Efficacy of AZD9291, Asia Pacific, NSCLC with T790M mutation within the Epidermal Growth Factor Receptor Gene

Summary:

      A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Asia
      Pacific Patients with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease
      has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
      Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor
      Receptor Gene
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged at least 18 years. Patient from Asia Pacific will be enrolled only.

          -  Locally advanced or metastatic NSCLC, not amenable to curative surgery or
             radiotherapy.

          -  Radiological documentation of disease progression on the last treatment administered
             prior to enrolling in the study: following 1st line EGFR TKI treatment but who have
             not received further treatment OR following prior therapy with an EGFR TKI and a
             platinum-based doublet chemotherapy. Patients may have also received additional lines
             of treatment.

          -  Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to
             be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R,
             L861Q).

          -  Patients must have central confirmation of tumour T790M mutation positive status from
             a biopsy sample taken after confirmation of disease progression on the most recent
             treatment regimen.

          -  World Health Organisation (WHO) performance status 0-1 with no deterioration over the
             previous 2 weeks and a minimum life expectancy of 12 weeks.

          -  At least one lesion, not previously irradiated and not chosen for biopsy during the
             study screening period, that can be accurately measured at baseline as ≥10mm in the
             longest diameter (except lymph nodes which must have short axis ≥15mm) with
             computerised tomography (CT) or magnetic resonance imaging (MRI) which is suitable for
             accurate repeated measurements.

          -  Females of child-bearing potential using contraception and must have a negative
             pregnancy test.

        Exclusion Criteria:

          -  Treatment with an EGFR-TKI (eg, erlotinib, gefitinib, icotinib or afatinib) within 8
             days or approximately 5x half-life of study entry; any cytotoxic chemotherapy,
             investigational agents or other anticancer drugs within 14 days of study entry;
             previous treatment with AZD9291 or a 3rd generation EGFR TKIs; Major surgery within 4
             weeks of study entry; radiotherapy treatment to more than 30% of the bone marrow or
             with a wide field of radiation within 4 weeks of study entry; currently receiving
             treatment with potent inhibitors or inducers of CYP3A4.

          -  Any unresolved toxicities from prior therapy.

          -  Unstable spinal cord compression or brain metastases.

          -  Severe or uncontrolled systemic diseases, including uncontrolled hypertension and
             active bleeding diatheses or infection.

          -  Refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.

          -  Cardiac disease.

          -  Past medical history of interstitial lung disease, drug-induced interstitial lung
             disease, radiation pneumonitis which required steroid treatment, or any evidence of
             clinically active interstitial lung disease.

          -  Inadequate bone marrow reserve or organ function.