AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:1/26/2019
Start Date:December 3, 2014
End Date:June 28, 2019

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A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

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

This is a Phase III, double-blind, randomised study assessing the efficacy and safety of
AZD9291 (80 mg orally, once daily) versus a standard of care (SoC) Epidermal Growth Factor
Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) (either gefitinib [250 mg orally, once daily]
or erlotinib [150 mg orally, once daily]) in patients with locally advanced or metastatic
Non-small Cell Lung Cancer (NSCLC) that is known to be EGFR sensitising mutation (EGFRm)
positive, treatment-naïve and eligible for first-line treatment with an EGFR-TKI.

Inclusion Criteria:

1. Male or female, aged at least 18 years.

2. Pathologically confirmed adenocarcinoma of the lung.

3. Locally advanced or metastatic NSCLC, not amenable to curative surgery or
radiotherapy.

4. The tumour harbours one of the 2 common EGFR mutations known to be associated with
EGFR-TKI sensitivity (Ex19del, L858R).

5. Mandatory provision of an unstained, archived tumour tissue sample in a quantity
sufficient to allow for central analysis of EGFR mutation status.

6. 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).

7. Provision of informed consent prior to any study specific procedures, sampling, and
analysis.

8. 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:

1. 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 potent
inducers of cytochrome P450 (CYP) 3A4.

- Alternative anti-cancer treatment

- Treatment with an investigational drug within five half-lives of the compound or
any of its related material.

2. Any concurrent and/or other active malignancy that has required treatment within 2
years of first dose of study drug.

3. 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.

4. 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).

5. 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.

6. 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 QTcF 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.

7. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required
steroid treatment, or any evidence of clinically active ILD.

8. Involvement in the planning and/or conduct of the study
We found this trial at
15
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Salisbury, North Carolina 28144
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