A placebo controlled study comparing AZD1775+ Docetaxel versus placebo+Docetaxel to treat lung cancer - None

Inclusion Criteria

• •Provision of informed consent prior to any study specific procedures
• •Histologic or cytologic diagnosis of advanced NSCLC, excluding large cell neuroendocrine, and mixed NSCLC/small-cell histologies
• •Failure of one prior platinum-based doublet treatment for advanced NSCLC (either due to progressive disease or toxicity)
• •Measurable disease as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1
• •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• •Mandatory availability of tumour tissue (archival or fresh if archival is not available) for TP53 testing
• •Male or female ≥18 years-of-age
• •Subjects may have received radiation for palliation prior to starting study treatment if they have recovered from the side effects of such therapy
• •Absolute neutrophil count (ANC) ≥1500/μL
• •Haemoglobin (Hgb) ≥9 g/dL
• •Platelets ≥100,000/uL
• •Adequate liver function defined as:
• •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal limits (WNL) or ≤2.5 x upper limit of normal (ULN), if liver metastases are present
• •Serum bilirubin WNL
• •Adequate renal function
• •Ability to swallow oral medication
• •Fertile male subjects willing to use at least one medically acceptable form of birth control for the duration of the study and for 2 weeks after treatment stops
• •Female subjects who are not of childbearing potential and fertile female subjects of childbearing potential who agree to use adequate contraceptive measures
• •Predicted life expectancy ≥12 weeks
• •Willingness and ability to comply with study and follow-up procedures
• •Ability to understand the investigational nature of this study and give written informed consent
• •Most recent chemotherapy ≤21 days or have not recovered from the side effects > Grade 1.
• •Use of a study drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775
• •Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting AZD1775 or has not recovered from side effects of such therapy
• •Major surgical procedures ≤28 days of beginning AZD1775, or minor surgical procedures ≤7 days
• •Known central nervous system (CNS) disease
• •Any known hypersensitivity or contraindication to the components of study treatment (AZD1775 and docetaxel)
• •Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association [NYHA] ≥ Class 2
• •Pregnant or lactating
• •Concurrent administration of medications or foods that are strong inhibitors of
• •Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the subject to receive protocol treatment
• •Presence of other active cancers, or history of treatment for invasive cancer ≤3 years
• •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol