A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer
Condition: Previously Treated Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: AZD1775; AZD1775 Placebo; Antimitotic Agent; pegfiligrastim
Intervention description: AZD 1775 + antimitotic agent+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity; Placebo (to match dose) + antimitotic+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity; The antimitotic is a drug that stops cells from dividing. This leads to cell death. Because cancer cells divide faster than normal cells, they are more likely than normal cells to be affected by this drug.; Pegfilgrastim is a man-made version of a protein called granulocyte-colony stimulating factor (G-CSF). This protein is made by cells in the body to stimulate the bone marrow to make more infection-fighting white blood cells.Pegfilgrastim is made by attaching filgrastim to a molecule called polyethylene glycol (PEG). This addition helps it stay in the body longer than filgrastim, which means it can be given less often.
Intervention MeSH terms: Antimitotic Agents; Adavosertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC

Summary:

      A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus
      antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell
      Lung Cancer Patients
    

Eligibility criteria:

        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