Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : AZD9291 80 mg/40mg + placebo, Placebo Erlotinib 150/100mg, Placebo Gefitinib 250mg
INN of investigational material : -
Therapeutic category code : 429 Ot
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Pathologically confirmed adenocarcinoma of the lung - Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy - The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R) - Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status - Patients must be treatment-naive for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents) - Provision of informed consent prior to any study specific procedures, sampling, and analysis. - World Health Organization Performance Status of 0 to 1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks 18 Years and older(Japan:20 Years and older)
Exclusion criteria
Exclusion criteria: - Treatment with any of the following: >Prior treatment with any systemic anti-cancer therapy for locally advanced/metastatic NSCLC. >Prior treatment with an EGFR-TKI >Major surgery within 4 weeks of the first dose of study drug >Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug >Patients currently receiving medications or herbal supplements known to be potentinducers of cytochrome P450(CYP)3A4 >Alternative anti-cancer treatment >Treatiment with an investigational drug within five-lives of the compound or any of its related material - Any concurrentand/or other active malignancy that has required treatment within 2 yeaers of first dose of study drug - Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids - Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) - Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291 - Any of the following cardiac criteria: >Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value >Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG >Any patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval - Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD - Involvement in the planning and/or conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics efficacy - | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed