Status:
COMPLETED
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief 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 Ca...
Detailed Description
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) Tyro...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
- 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 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.
- 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
Key Trial Info
Start Date :
December 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2025
Estimated Enrollment :
674 Patients enrolled
Trial Details
Trial ID
NCT02296125
Start Date
December 3 2014
End Date
November 20 2025
Last Update
January 9 2026
Active Locations (170)
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1
Research Site
Anaheim, California, United States, 92801
2
Research Site
Santa Rosa, California, United States, 95403
3
Research Site
West Hills, California, United States, 91307
4
Research Site
Tampa, Florida, United States, 33612