AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small C… (NCT02296125) | Clinical Trial Compass
CompletedPhase 3
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
United States674 participantsStarted 2014-12-03
Plain-language summary
To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Male or female, aged at least 18 years.
✓. 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-naïve 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
Exclusion criteria
✕. Treatment with any of the following:
✕. Any concurrent and/or other active malignancy that has required treatment within 2 years 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.
What they're measuring
1
Median Progression Free Survival (PFS) (Months)
Timeframe: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
2
Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months
Timeframe: At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
✕. 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:
✕. 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